Biomet EBI Bone Healing System 1068240Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00812301020621), received between May 24, 2019 and Jun 22, 2026 — classified as 61 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (27 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  THE SALES REP ADVISED THAT THE PATIENT HAD PAIN WHILE USING THE BHS. THE PATIENT WAS CALLED TO COLLECT ADDITIONAL INFORMATION BUT A VOICEMAIL HAD TO BE LEFT. NO NEW PRODUCT WAS SHIPPED TO THE PATIENT.

  Patient problems: Pain

  MAUDE report 25580370 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THEIR FRACTURE SITE WHEN DURING TREATMENT WITH THE DEVICE. IT WAS LATER REPORTED THAT AFTER CONDUCTING A TIME TEST, THE PATIENT CONTINUED TO EXPERIENCE PAIN. THE PATIENT STATED THAT THE PAIN STARTS ABOUT AFTER 2 HOURS OF TREATMENT AND RATED THE PAIN LEVEL A 5 OUT OF 10. THE PATIENT STATED THAT AT APPROXIMATELY 3 HOURS OF TREATMENT, THE PAIN BECOMES UNBEARABLE AND INCREASES TO A 10 OUT OF 10. AT THIS POINT THE PATIENT REMOVES THE DEVICE. THE PATIENT STATED THAT THE PAIN IS ONLY AT THE FRACTURE SITE, THERE IS NO REDNESS OR SWELLING IN THE AREA. THE PATIENT DISCUSSED THE ISSUE WITH THEIR DOCTOR BUT DID NOT REQUIRE ANY MEDICAL INTERVENTION. THE PATIENT WILL CONTINUE TREATMENT AND LIMIT TREATMENT PERIODS TO 3 HOURS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 25334517 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S FOOT HURT DURING TREATMENT. THE PATIENT STATED THAT THE PAIN STARTED A FEW DAYS AFTER RECEIVING THE UNIT. THE PATIENT RATED THE PAIN LEVEL A 12 OUT OF 10 WITH 10 BEING THE HIGHEST. THE PAIN SUBSIDED WHEN THE PATIENT PAUSED TREATMENT. THE PATIENT DID NOT DISCUSS THE ISSUE WITH THEIR DOCTOR AND IS TAKING IBUPROFEN FOR THE PAIN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 25159082 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT HE IS IN PAIN. IT FEELS LIKE A NEEDLE INSIDE. IT IS A BURNING PAIN AND THE PAIN LEVEL IS WAY OVER 10. THE SKIN IS RED. THE SKIN IS SLIGHTLY WARMER THAN THE REST OF HIS BODY. ON WEDNESDAY IT LOOKED LIKE RED DOTS. TODAY IT LOOKS VERY RED ON THE AREA. THE PATIENT STARTED ABOUT 2 MONTHS AGO. THE PATIENT DID MENTION THIS TO HIS DOCTOR AND THE DOCTOR TOLD HIM THIS WAS THE HEALING PROCESS. THE PAIN IS ONLY WHEN HE IS WEARING THE UNIT. WHEN HE TAKES IT OFF THE PAIN DIMINISHES AND GOES AWAY AFTER AN HOUR OR SO. THE AREA THAT IS RED GETS IRRITATED WHEN HE IS WEARING HIS SHOES. THE CUSTOMER SERVICE REPRESENTATIVE OFFERED TO REPLACE HIS UNIT AND COIL AND THE PATIENT DECLINED SAYING HE DOES NOT WANT TO DELAY THE HEALING. HE ALSO WANTED TO REVIEW THE PLACEMENT OF THE COIL. THE CUSTOMER SERVICE REPRESENTATIVE ADVISED SHE WOULD HAVE HIS SALES REPRESENTATIVE (B)(6) CALL HIM REGARDING THIS ISSUE. THE CUSTOMER SERVICE REPRESENTATIVE CALLED (B)(6) AND EXPLAINED THE PATIENT'S ISSUE. SHE ADVISED NOT TO SEND ANY NEW PRODUCT AS SHE WILL CONTACT THE PATIENT AND ADVISE HIM TO VISIT THE DOCTOR. (B)(6) NOTED THIS MAY BE A NEW MEDICAL ISSUE SINCE THERE WAS NO PAIN FOR OVER A

  Patient problems: Pain

  MAUDE report 24344121 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT HE TREATS 7 TO 10 HOURS AT NIGHT. THE PATIENT STATED THAT THIS CAUSED HIM PAIN AND HE TOOK IT OFF. THE PATIENT PUT THE UNIT ON AT 9:30PM AND REMOVES IT AT 4AM AND HE HAS NOT EXPERIENCED ANY PAIN SINCE THEN. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION

  Patient problems: Pain

  MAUDE report 23391330 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT WHILE USING BHS UNIT, THE PATIENT FELT THE UNIT, AND IT WAS PAINFUL AFTERWARDS. THE PATIENT STATED THAT THEY HAD SHARP PAIN IN FOOT AND PAIN LEVEL WAS AT 10 ON A SCALE OF 1-10. THE PAIN SUBSIDED WHEN THE PATIENT WAS NOT TREATED. THE PATIENT DID NOT INCREASE ANY ACTIVITY. THE PATIENT SPOKE TO THEIR DOCTOR WHO ADVISED THEM TO STOP TREATING OVER THE WEEKEND AND WOULD SWITCH THE PATIENT TO DIFFERENT UNIT. NO FURTHER CONSEQUENCES WERE REPORTED. THE BHS ASSEMBLY AND SFLX XL COILETTE WERE NOT RETURNED.

  Patient problems: Pain

  MAUDE report 22937385 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED PAIN WHILE USING THE BONE STIMULATOR 10 HOURS PER DAY. THE SALES REPRESENTATIVE ADVISED THE PATIENT TO CONDUCT TIME-TEST.

  Patient problems: Pain

  MAUDE report 22883744 ↗
• InjuryMay 22, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE TREATMENT COIL ALMOST CAUGHT FIRE WHILE IT WAS ON HER FOOT. THE PATIENT STATED THAT IT BECAME EXTREMELY HOT TO TOUCH AND THAT SHE DOES NOT WANT A REPLACEMENT COIL, NOR DOES SHE WANT TO CONTINUE USING THE DEVICE. THE PATIENT STATED THAT THERE WAS NO INJURY TO HER FOOT, BUT IT WAS SORE FOR SEVERAL DAYS. THE INCIDENT OCCURRED IN JANUARY, BUT THE PATIENT DID NOT CONTACT THE SALES REPRESENTATIVE OR CUSTOMER SERVICE. THE PATIENT TREATED WHILE SLEEPING AND COVERED. THE PATIENT STATED THAT THE COIL GOT VERY HOT ON HER FOOT AND HAD TO QUICKLY TAKE THE DEVICE OFF BEFORE IT BURNED HER. THE SKIN WAS RED WITH NO BLISTERS AND NO OTHER MARKS. THE PATIENT STATED THAT SHE DID NOT RECEIVE ANY TREATMENT, NOR DID SHE TREAT THE AFFECTED AREA HERSELF. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED SORENESS AND PAIN/DISCOMFORT WHICH WAS RATED AT A 10 ON A SCALE OF 1-10, WITH 10 BEING THE WORST. THE PATIENT DID NOT CONTACT HER DOCTOR REGARDING THE PAIN OR DISCOMFORT BUT DISCONTINUED USING THE DEVICE IMMEDIATELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Erythema; Pain

  MAUDE report 22073405 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT WAS EXPERIENCING PAIN. IT WAS LATER REPORTED BY THE PATIENT THAT HER PAIN INCREASES WHEN SHE IS TREATING WITH THE UNIT. THIS HAS BEEN OCCURRING SINCE THE PATIENT STARTED TREATMENT. THE PATIENT HAS NOT INCREASED HER LEVEL OF DAILY ACTIVITY. THE PATIENT IS ONLY TREATING DURING THE DAY FOR AROUND 8 HOURS PER DAY IT WAS LATER REPORTED THAT THE PAIN LEVEL IS A 5 ON A SCALE OF 1-10, WITH 10 BEING THE WORST. THE PATIENT STARTED TREATING FOR UP TO 4 HOURS PER DAY AND WILL CONTINUE TO INCREASE HER TREATMENT TIME. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT IS TREATING FOR ABOUT 4 TO 5 HOURS OR UNTIL SHE EXPERIENCES PAIN. THE PAIN WAS RATED A 9 ON A SCALE OF 1-10. THE PATIENT CONTACTED THEIR DOCTOR DUE TO THE PAIN AND WAS PRESCRIBED PERCOCET. THE PATIENT IS GOING TO CONTINUE TREATMENT AS MUCH AS SHE CAN TOLERATE. NO FURTHER INFORMATION WAS PROVIDED. THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION.

  Patient problems: Pain

  MAUDE report 21921091 ↗
• InjuryApr 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE DOCTOR INDICATED THAT THE PATIENT HAD NAUSEA, DIARRHEA AND PAIN FROM BHS UNIT. LATER, THE CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT STATED THAT SHE HAD NAUSEA, DIARRHEA AND PAIN WHILE USING THE STIM. THE PATIENT INDICATED THAT THEY ARE TAKING PAIN MEDICATION PERCOCET AND NAUSEA MEDICATION. THE PATIENT TREATED FOR 4 TO 5 HOURS OR UNTIL FELT PAIN, THE PATIENT IS GOING TO CONTINUE THE TREATMENT UNLESS OTHERWISE SPECIFIED. THE PATIENT WILL CALL BACK WITH ANY UPDATES. LATER, THE COMPLAINT SPECIALIST CALLED THE PATIENT TO VERIFY IF THERE WAS ANY OTHER MEDICAL INTERVENTION AND VERIFY ONSET OF NAUSEA/ DIARRHEA SYMPTOMS BUT HAD TO LEAVE A VOICEMAIL MESSAGE REQUESTING FOR A CALL BACK. A CALL BACK WAS RECEIVED FROM THE PATIENT INDICATING THAT NAUSEA AND DIARRHEA STARTED LAST MONTH- (B)(6) 2025. THE PATIENT CONTACTED HER PRIMARY CARE DOCTOR AND WAS PRESCRIBED NAUSEA MEDICATION. THE PATIENT STATED THAT SHE TAKES THE MEDICATION AS NEEDED AND CONTINUES THE USE OF BONE STIM. NO FURTHER CONSEQUENCES ARE REPORTED. THE SFLX-XL COILETTE WAS NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Diarrhea; Nausea

  MAUDE report 21876452 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT HAS PAIN WHILE USING THE UNIT AND THE SALES REPRESENTATIVE ADVISED THE PATIENT TO CONDUCT TIME TEST. LATER, THE CUSTOMER SERVICE REPRESENTATIVE CALLED THAT PATIENT TO GATHER MORE INFORMATION, HOWEVER HAD TO LEAVE A VOICEMAIL. ON MARCH 17 2025, A CALL WAS RECEIVED FROM PATIENT WHO STATED THAT SHE HAD PAIN AFTER 3 HOURS OF TREATMENT. IT STARTED THE FIRST DAY SHE STARTED TREATING ON THE RIGHT FOOT. THE PAIN IS ON THE TOP OF THE FOOT WHERE THE BONE IS FRACTURED. THE PAIN LEVEL IS LIKE AN 8 AND THE PATIENT HAS DISCONTINUED THE TREATMENT. AFTER THE PATIENT STOPS TREATING, SHE FALLS BACK ASLEEP AND DOES NOT KNOW HOW LONG IT TAKES THE PAIN TO GO AWAY. THE PATIENT HAS NOT INCREASED HER DAILY ACTIVITIES BUT IS WALKING WITH THE INJURED FOOT. THE PATIENT DOES NOT TAKE ANYTHING FOR PAIN AND ONLY CONTACTED THE SALES REPRESENTATIVE, DID NOT CALL THE DOCTOR. THE PATIENT IS DOING TIME TEST AND IS UP TO 4 HOURS A DAY. THE PATIENT WILL CALL US WITH ANY UPDATES. NO FURTHER CONSEQUENCES WERE REPORTED. THE BHS UNIT AND SFLX-XL COILETTE WERE NOT RETURNED FOR INVESTIGATION.

  Patient problems: Pain

  MAUDE report 21708893 ↗
• InjuryMar 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT EXPERIENCED PAIN WHILE USING THE BHS ASSEMBLY. THE PATIENT INDICATED THAT THE PAIN LEVEL WAS AT A 8 OR 10 ON A SCALE OF 1 TO10, 10 BEING THE WORST. THE PATIENT CONTACTED THEIR DOCTOR, AND THE PHYSICIAN ADVISED THE PATIENT TO STOP USING THE UNIT. NO FURTHER CONSEQUENCES ARE REPORTED. THE BHS UNIT AND SFLX-XL COILETTE WERE NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 21667793 ↗
• InjuryMar 17, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT EXPERIENCED DISCOMFORT WHILE USING THE BHS ASSEMBLY. THE PATIENT INDICATED THAT THE AREA OF TREATMENT IS SORE AND HAS PAIN AFTER SHE USES THE STIM. THE PATIENT WORE THE UNIT FOR 6 TO 10 HOURS WHEN SHE HAD DISCOMFORT. THE PATIENT CONTACTED THEIR DOCTOR, AND THE PHYSICIAN ADVISED ONLY TO TREAT FOR 1 HOUR A DAY. THE PATIENT WAS GOING TO CONDUCT THE TIME-TEST AND CALL BACK IF THEY FACE ANY ISSUE. NO FURTHER CONSEQUENCES ARE REPORTED. THE BHS UNIT, SFLX COILETTE AND SFLX-XL COILETTE WERE NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Discomfort; Pain

  MAUDE report 21619579 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT TOLD HER THAT SHE WOKE UP ON FRIDAY AND HER TOE FELT LIKE IT WAS ON FIRE. SHE STATED SHE HAD THE UNIT ON FOR 3 OR 4 HOURS. WHEN SHE TOOK THE UNIT OFF THE BURNING STOPPED. LAST NIGHT SHE HAD THE UNIT ON FOR ABOUT 8 HOURS AND SHE FELT THE BURNING AGAIN. THE REP ADVISED THE PATIENT TO TAKE A BREAK FROM TREATING AND ONLY WEAR THE UNIT FOR 1 HOUR PER DAY. THE CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT FOR DETAILS BUT HAD TO LEAVE A VOICEMAIL FOR A RETURN CALL. NO PRODUCT WAS SHIPPED. LATER, THE PATIENT CALLED IN RESPONSE TO A FOLLOW-UP LETTER SENT REGARDING THE BONE STIMULATOR. PER PRODUCT SURVEILLANCE SPECIALIST, THE PATIENT ONLY EXPERIENCED THE BURNING SENSATION WHEN SHE WAS SLEEPING, WHEN ASKED TO RATE THE PAIN LEVEL SHE SAID WAS NEAR 1000 AND AS SOON AS SHE REMOVED THE COIL THE PAIN STOPPED RIGHT AWAY. THE PATIENT SPOKE WITH HER DOCTOR WHO DID NOT PRESCRIBE ANYTHING AND TOLD HER TO TREAT DURING THE DAY FOR 4 HOURS PER DAY. PATIENT DESCRIBED THE PAIN AS PUTTING A LIT MATCH ON HER SKIN. NO FURTHER CONSEQUENCES ARE REPORTED. THE BHS CONTROLLER AND SFLX-XL COILETTE WERE NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain; Paresthesia

  MAUDE report 21470933 ↗
• InjuryJan 14, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT EXPERIENCED PAIN WHILE USING SFLX-XL COILETTE. THE PATIENT INDICATED THAT THE PAIN LEVEL WAS 7 OR 8 OUT OF 10.NO FURTHER INFORMATION HAS BEEN REPORTED. THE SFLX-XL COILETTE HAS NOT BEEN RETURNED FOR EVALUATION.

  Patient problems: Pain

  MAUDE report 21148793 ↗
• InjuryJan 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT HAD DISCOMFORT AND NUMBNESS WHILE TREATING. THE CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT FOR DETAILS AND FOUND THAT AFTER USING THE BHS FOR 30 MINUTES SHE HAD A FOOT CRAMP. THEN, SHE PUT THE COIL ON FOR 1 1/2 HOURS AND THE FOOT WAS COLD AND TINGLY. THE PATIENT USED IT AGAIN IN THE MORNING WITH THE SAME RESULT. THE PATIENT SPOKE WITH HER DOCTOR¿S OFFICE, AND THEY ADVISED HER TO STOP WEARING THE UNIT AND IF THE FOOT CONTINUES TO FEEL COLD AND TINGLY TO GO TO THE ER AND MAKE SURE THE BLOOD VESSELS ARE WORKING. THE PATIENT STATED THE COLD FOOT, AND TINGLING HAS NOT STOPPED SINCE LAST NIGHT. THE PATIENT IS GOING TO THE ER IF THE FOOT DOES NOT STOP FEELING COLD AND WILL CALL BACK WITH AN UPDATE. NO FURTHER CONSEQUENCES ARE REPORTED. THE BHS CONTROLLER AND SFLX-XL COILETTE WERE NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Neuropathy; Numbness

  MAUDE report 21138771 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STARTED TO FEEL SOME INTERNAL TREMORS AROUND THE SAME TIME SHE STARTED USING THE DEVICE. THE PATIENT WAS TREATING 10 HOURS PER DAY EVERY DAY. THE PATIENT EXPERIENCED INTERMITTENT TREMORS BOTH WITH THE DEVICE ON AND WHEN NOT WEARING THE DEVICE. THERE WAS NO PAIN ASSOCIATED WITH THE SENSATION. THE PATIENT WAS AFRAID TO PUT THE DEVICE BACK ON AS SHE DOES NOT WANT THE TREMORS TO RETURN. THE PATIENT STATED THE SENSATION IS SIMILAR TO SITTING ON A VIBRATING PAGER, BUT SHE DOES NOT HEAR ANY VIBRATION FROM THE DEVICE. THE VIBRATING SENSATION SPREADS FROM HER FOOT UP TO HER CHEST. NO ISSUES WITH THE CHEST AND ABOVE. THE VIBRATING SENSATION MAKES HER A BIT DIZZY WHEN WALKING AROUND. THE PATIENT IS WEARING THE COIL ON HER LEFT FOOT. THE PATIENT HAS BRITTLE BONES IN HER LOWER SPIN AND IS UNSURE IF THAT MAY BE RELATED TO THE ISSUE. THE PATIENT HAS AN APPOINTMENT WITH HER SPINAL DOCTOR ON (B)(6) 2024. THE PATIENT¿S SCANS ARE SHOWING GOOD HEALING AND HER FOOT FEELS MUCH BETTER SO SHE DOES WANT TO CONTINUE TREATING BUT IS AFRAID THE BONES IN HER BACK MAY BE AFFECTED. IT WAS LATER REPORTED THAT THE PATIENT WENT TO (B)(6) AND WAS ADVISED TO DISCONTINUE USE OF THE DEV

  Patient problems: Dizziness; Pain; Shaking/Tremors

  MAUDE report 21136881 ↗
• InjuryDec 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT THAT SHE HAD EXTREME PAIN WHILE USING BHS UNIT AND SFLX-XL COILETTE. THE PAIN WAS AT 8-10 ON A SCALE OF 1-10, 10 BEING THE WORST. THE PATIENT STATED THAT SHE PULLED OFF HER SOCK AND RIPPED THE COIL OFF HER FOOT AS SOON AS SHE WOKE UP. ONCE COIL WAS REMOVED PAIN SUBSIDED. THE PATIENT DID NOT CONTACT HER DOCTOR NOR TOOK ANY MEDICATIONS. THE COIL WAS MAKING A HUMMING/ CLICKING SOUND. NO FURTHER CONSEQUENCES ARE REPORTED. THE BHS CONTROLLER AND SFLX-XL COILETTE WERE NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 20990071 ↗
• InjuryNov 4, 2024Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF PINS AND NEEDLES ON THE TOES OF HER LEFT FOOT AND ON HER FEMUR OF THE OPPOSITE LEG. IT WAS NOTED THAT THE COIL DOES NOT TOUCH THE PATIENT¿S TOES. IT WAS LATER REPORTED THAT THE PATIENT FELT AN ELECTRIC SHOCK THE FIRST TIME SHE USED THE STIMULATOR ON HER LEFT FOOT. THE PATIENT WAS EXPERIENCING PAIN AND WENT TO THE ORTHOPEDIST WHO RECOMMENDED USING THE UNIT FOR 5 HOURS. THE PATIENT RATED THE PAIN AS A 10 ON A SCALE OF 1-10, WITH 10 BEING THE HIGHEST. THE PATIENT CONTINUED TO FEEL A TINGLING SENSATION ON THE LEFT FOOT AND THE PAIN COMES AND GOES. IT WAS LATER REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT WAS TREATING WITH THE SFLX XL COILETTE.

  Patient problems: Pain; Paresthesia

  MAUDE report 20602753 ↗
• InjuryAug 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT FELT PAIN WHILE USING THE SFLX- XL COILETTE. NO FURTHER INFORMATION HAS BEEN REPORTED. THE SFLX- XL COILETTE HAS NOT BEEN RETURNED FOR EVALUATION.

  Patient problems: Pain

  MAUDE report 19951716 ↗
• InjuryAug 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT FELT PAIN WHILE USING THE SFLX- XL COILETTE. NO FURTHER INFORMATION HAS BEEN REPORTED. THE SFLX- XL COILETTE HAS NOT BEEN RETURNED FOR EVALUATION.

  Patient problems: Pain

  MAUDE report 19905814 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER TAKING THE DEVICE OFF, THE PATIENT FEELS PAIN ON HER SMALL TOE RADIATING TO THE WHOLE FOOT. THE PATIENT STATED THAT THE PAIN STARTED LAST FRIDAY AND THE PAIN LEVEL IS AN 8 OUT OF 10. THE PATIENT ADVISED SHE HAS NOT BEEN ABLE TO WALK DUE TO THE PAIN. THE PATIENT HAS BEEN PUTTING A BANDAGE AROUND THE TOE AND IT DECREASES THE PAIN. THE PATIENT HAS NOT INCREASED HER DAILY ACTIVITY. THE PATIENT MENTIONED THE ISSUE TO HER DOCTOR LAST THURSDAY AT HER VISIT, BUT THE PAIN INCREASED ON FRIDAY TO THE POINT SHE CANNOT PUT HER FOOT ON THE FLOOR. THE DOCTOR TOLD HER TO CONTINUE USING THE DEVICE FOR 2 MONTHS. NOTHING WAS PRESCRIBED FOR THE PAIN.

  Patient problems: Pain

  MAUDE report 19806341 ↗
• InjuryMar 21, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 18956148 ↗
• InjuryMar 5, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT HIS ELBOW WAS IN PAIN BECAUSE OF THE INFLAMMATION. HE HAS BEEN WEARING THE UNIT FOR 50 DAYS. THE PATIENT HAD TO GET ELBOW DRAINED A FEW TIMES. THE PATIENT WAS ADVISED TO STOP & CONDUCT A TIMED TEST AND CALL BACK IF ANY ISSUES. THE PATIENT WOULD ALSO CONTACT HIS DOCTOR. HE WANTED TO KNOW HOW LONG HE HAD TO WEAR THE UNIT. THE PATIENT WAS ADVISED TO CALL HIS DOCTOR TO MONITOR HIS HEALING PROGRESS. THE PATIENT STATED THE PAIN WAS MORE OF AN ACHY FEELING AND SAID IT WAS A 2 OR 3 OUT OF 10. THE PATIENT STATED THAT THIS WOULD OCCUR WHEN HE WOKE UP EACH MORNING. THE PATIENT IS CONTINUING TO TREAT AND IS FEELING BETTER USING THE DEVICE. THE PATIENT STATED THAT HE DID HE SPOKE TO THE DOCTOR, AND HE WANTS HIM TO CONTINUE USING THE BONE STIMULATOR AND DID NOT SUGGEST NOR PRESCRIBE ANY MEDICATION.

  Patient problems: Itching Sensation; Pain

  MAUDE report 18843028 ↗
• InjuryFeb 29, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN WITH THE BHS AND COIL. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Pain

  MAUDE report 18813034 ↗