Biomet EBI Bone Healing System 1068234Recalls & reported problems

Summary

The FDA's MAUDE database contains 171 adverse event reports that list this exact device (DI 00812301020560), received between Apr 16, 2019 and May 29, 2026 — classified as 171 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (75 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 171 reports, in the reporter's own words as published by the FDA.

• 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 25334506 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AND SWELLING. THE PATIENT STATED THAT THEIR USUAL DISCOMFORT WAS RATED 6 OUT OF 10, AND WHEN PUTTING WEIGHT ON THE FOOT THE DISCOMFORT IS AN 8 OUT OF 10. THE PATIENT STATED THAT SOME DAYS THEY DID NOT TREAT WITH THE BONE HEALING SYSTEM DEVICE AT ALL BECAUSE THE SFLX 3 COIL PUTS PRESSURE ON THEIR SWOLLEN TENDON. THE PATIENT NOTED THAT THEIR LEVEL OF ACTIVITY HAD NOT CHANGED RECENTLY BUT STATED THAT THEY BEGAN PUTTING WEIGHT ON THEIR FOOT APPROXIMATELY 3 WEEKS AGO. THE PATIENT BEGAN TAKING APPROXIMATELY 10 STEPS PER DAY, THEN RETURNING TO THE WHEELCHAIR. THE PATIENT¿S DOCTOR REQUESTED THAT THE PATIENT BE SWITCHED TO ANOTHER BONE GROWTH STIMULATOR AS THE PATIENT HAD NOT HAD ANY BONE GROWTH. AN ORTHOPAK DEVICE WAS SHIPPED TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Swelling/ Edema

  MAUDE report 25230633 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S FOOT HURT WHILE TREATING WITH THE BIOMET EBI BONE HEALING SYSTEM. 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 WAS NOT TREATING. 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 25159064 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S MOTHER REPORTED THAT THEIR ANKLE HAS BEEN SWOLLEN SINCE STARTING TO TREAT WITH THE DEVICE. THE COIL IS NOT TOO TIGHT. ON (B)(6) 2026, THE PATIENT¿S MOTHER SPOKE TO CUSTOMER SERVICE AND STATED HER SON HAD SWELLING AND PAIN, AND HE WAS NOT ABLE TO WALK. THE PATIENT HAS NOT INCREASED HIS DAILY ACTIVITIES. THE PATIENT WORKS AND STANDS. THE PATIENT USED ICE ON HIS FOOT AND TOOK IBUPROFEN. THEY DID NOT CALL THE DOCTOR. THE PAIN LEVEL WAS A 10, AND THE PATIENT COULD BARELY WALK. THE PATIENT WILL CONDUCT THE TIME TEST AND CAN CALL BACK IF THERE ARE ANY ISSUES. NO REPLACEMENT PRODUCT WAS SHIPPED. NO FURTHER CONSEQUENCES ARE REPORTED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 24845665 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED EXPERIENCING PAIN WHILE TREATING. THE SALES REP ADVISED THE PATIENT TO STOP WEARING THE UNIT. NO FURTHER CONSEQUENCES WERE REPORTED. THE BHS ASSEMBLY WAS NOT RETURNED.

  Patient problems: Pain

  MAUDE report 24616629 ↗
• 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 24344003 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE EXPERIENCED PAIN AFTER FIVE HOURS OF TREATMENT. THE PATIENT WILL COMPLETE THE TIME TEST, STARTING AT 4 HOURS PER DAY FOR 2 DAYS. INCREASING BY AN HOUR EVERY TWO DAYS. IT WAS LATER REPORTED THAT THE PATIENT STOPPED EXPERIENCING PAIN AFTER REDUCING TREATMENT TIME. THE PATIENT TREATS DURING THE DAY AND REMOVES THE DEVICE AT NIGHT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 24086158 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED SHE WAS IN A LOT OF PAIN WHILE TREATING. THE PATIENT STATED THAT SHE WORE THE UNIT FOR 5 HOURS. THEN TOOK A BREAK FOR A FEW HOURS. THEN WORE IT AGAIN FOR 90 MINUTES AND BEGAN FEELING PAIN. THE PATIENT DID NOT TELL THE DOCTOR, ONLY THE SALES REP. THE PATIENT WILL CONDUCT THE TIME TEST AND CALL BACK WITH ANY ISSUES. NO FURTHER CONSEQUENCES ARE REPORTED.

  Patient problems: Pain

  MAUDE report 23960009 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED FEELING PAIN AFTER HE TAKES THE UNIT OFF, AND HE IS MOVING AROUND. THE PATIENT WORE THE UNIT ON HIS FOOT FOR 10 HOURS FOR 8 DAYS. PATIENT DID NOT SPEAK TO HIS DOCTOR ONLY THE SALES REP. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 23604397 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED EXPERIENCING IRRITATION WITH THE COIL, THE PATIENT STATED IT IS ON THE LATERAL SIDE OF HER KNEE. PATIENT SAID THE COIL IS NOT TIGHT, IT IS A RAISED AREA. SHE WORE THE UNIT FOR 2 MONTHS STATED IT STARTED ABOUT A WEEK - 2 WEEKS AGO. PATIENT IS ACTIVE BUT NOT WITH THE UNIT. THE PATIENT USES A WALKER AND SHE TREATS AT NIGHT. THE PATIENT WAS ADVISED TO STOP WEARING THE UNIT AND CALL THE DOCTOR. PATIENT WILL CALL BACK WITH AN UPDATE. CS SPOKE WITH THE PATIENT AND SHE STATED IT IS NOT FROM THE COIL RUBBING ON HER SKIN. SALES REP STATED THAT THE DOCTOR WAS THE ONE TO CALL THEM AND REQUESTED A SWITCH TO AN OPAK. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 23572451 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER SALES REP EMAIL PATIENT CLAIMING HE HAD BLISTER AND PAIN WHEN HE USED THE STIMULATOR IN SEPTEMBER. HE STOPPED BUT THE SURGEON WANTS HIM TO START USING IT AGAIN. CALLED THE PATIENT COULD NOT LEAVE A MESSAGE THE MAILBOX WAS FULL.

  Patient problems: Pain

  MAUDE report 23372947 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SALES REP ADVISED THAT THE PATIENT IS EXPERIENCING PAIN AFTER 4 HOURS WHILE USING THE BHS. THE PATIENT WAS CALLED AND ADVISED THAT SHE HAD ANKLE PAIN AND WORE IT FOR 10 HOURS. THE PATIENT DID NOT CALL THE DOCTOR, SHE CALLED THE SALES REP, WAS ADVISED TO DO A TIME TEST. NO NEW PRODUCT WAS SHIPPED TO THE PATIENT. NO FURTHER CONSEQUENCES ARE REPORTED. THE BHS UNIT AND SFLX COILETTE WERE NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 23365967 ↗
• InjuryOct 21, 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 23350898 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE EXPERIENCED PAIN WHILE TREATING. PATIENT SPOKE TO THE SALES REPRESENTATIVE AND HER DOCTOR WHO SUGGESTED THE TIME TEST AND EXPLAINED THE TIME TEST. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 23278723 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT IT WAS PAINFUL TO USE THE DEVICE FOR MORE THAN 45 MINUTES STRAIGHT. THE PATIENT STATED IT FELT PAINFUL, AS IF THEIR FOOT WAS BEING SQUEEZED AND THE METALS THAT WERE PLACED INSIDE WERE BEING PULLED OUT. THE PATIENT MENTIONED IT TO THEIR DOCTOR AND WAS ADVISED TO CONTACT THE SALES REPRESENTATIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 23051353 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TERRIBLE PAIN DURING THE NIGHT THAT OFTEN WOKE HER UP. THE PATIENT BELIEVES IT IS THE BONE GROWTH STIMULATOR. THE PATIENT WEARS THE DEVICE FROM 8PM TO 6AM EVERY NIGHT. ON (B)(6) 2025, THE PATIENT REMOVED THE DEVICE AT MIDNIGHT BECAUSE HER FOOT HURT SO MUCH AND REALIZED AFTER ABOUT 30 MINUTES SHE HAD NO PAIN. THE PATIENT STATED THAT SHE DOES NOT EXPERIENCE ANY PAIN DURING THE DAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 22992027 ↗
• 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 22937419 ↗
• InjuryAug 29, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXCRUCIATING PAIN AFTER 2 HOURS OF TREATMENT. THE PATIENT STATED THAT SHE IS FINE ALL DAY WITH NO PAIN BUT AFTER ABOUT 1 HOUR OF TREATMENT THE PAIN STARTS. THE PATIENT STATED THAT LAST NIGHT THE PAIN GOT SO BAD SHE HAD TO TAKE AN OXYCODONE. THE PATIENT HAS NOT DISCUSSED THE ISSUE WITH HER DOCTOR. THE PATIENT STATED SHE HAS NEVER SPOKEN WITH A SALES REPRESENTATIVE. PRODUCT SURVEILLANCE SPECIALIST (B)(4) GAVE THE PATIENT THE PHONE NUMBER FOR SUSAN RENDULIC WHO IS LISTED AS THE SALES REPRESENTATIVE IN FILENET AND ADVISED THE PATIENT TO CONTACT THE SALES REP WITH THE CONCERN. NOTE, THIS INFORMATION WAS OBTAINED DURING SECOND ATTEMPT CALL FOR (B)(4); (B)(4). UPDATE (B)(6): PER SECOND ATTEMPT CALL, THE PATIENT STATED THAT SHE HAD TO STOP USING THE UNIT DUE TO THE PAIN. THE PATIENT STATED THAT THE PAIN WAS EXCRUCIATING, RATED THE PAIN AN 8 OR 9 OUT OF 10. THE PATIENT REACHED OUT TO HER DOCTOR TO DISCUSS GETTING MORE PAIN MEDICATION BUT HER DOCTOR ADVISED HER TO STOP USING THE UNIT INSTEAD. THE PATIENT WAS ASKED IF SHE WOULD LIKE TO RETURN THE DEVICE FOR EVALUATION AND STATED SHE WOULD HAVE TO DISCUSS WITH HER DOCTOR, THE PATIENT MAY WANT TO RES

  Patient problems: Pain

  MAUDE report 22926713 ↗
• 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 22883427 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THE UNIT BURNED HER FOOT. THIS HAPPENED IN DECEMBER OR EARLY JANUARY. THE PATIENT REPORTED IT TO HER DOCTOR AND WAS PRESCRIBED HONEY CREAM. THE CREAM WAS RECALLED, AND THE DOCTOR GAVE THE PATIENT A SAMPLE OF SANTYL 30 GRAMS CREAM. THE BURN HEALED, AND THE PATIENT REQUESTED TO RESUME TREATMENT. IT WAS LATER REPORTED THAT THE BURN IS NOW COMPLETELY HEALED, THERE IS JUST A SCAR REMAINING. THE PATIENT ALSO STATED THAT THE DEVICE HAS EXPOSED WIRES ON THE CONTROLLER, BUT SHE HAD NOT NOTICED THE CONTROLLER GETTING WARM AFTER RESUMING TREATMENT. A REPLACEMENT CONTROLLER WAS SHIPPED TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 22839869 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE IS IN A LOT OF PAIN WHILE TREATING AND SOME HEAT. THE SALES REP SUGGESTED TIME TEST, THE PATIENT WILL START WITH 1 HOUR FOR 2 DAYS AND THEN INCREASE. CUSTOMER SERVICE CALLED THE PATIENT REGARDING THE PAIN AND HEAT. THE PATIENT SAID SHE WAS AT WORK AND REQUEST A CALL BACK AT ANOTHER TIME. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 22728817 ↗
• InjuryJul 31, 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 EXPERIENCED PAIN IN THE KNEE WHILE USING THE BHS ASSEMBLY. THE PATIENT DID NOT INDICATE THE PAIN LEVEL.

  Patient problems: Pain

  MAUDE report 22679140 ↗
• InjuryJul 29, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Pain

  MAUDE report 22644554 ↗
• 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 AT THE TIME. 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 22073311 ↗
• 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, 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 21920873 ↗