Bioinductive Implant with Arthroscopic Delivery System - Large 4566Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00885556735664), received between Jun 2, 2020 and Jun 6, 2026 — classified as 21 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A ROTATOR CUFF SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2026, THE PATIENT EXPERIENCED AN INFECTION THREE MONTHS LATER. IT IS UNKNOWN HOW THIS EVENT WAS SOLVED/TREATED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 25419238 ↗
• InjuryOct 2, 2025Migration; Migration

  IT WAS REPORTED THAT AFTER ROTATOR CUFF TENDON REPAIR SURGERY, THAT HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED THAT A BIOINDUCTIVE IMPLANT SEPARATED OFF, THE UNIT DID NOT IMPLANT CORRECTLY, IT WAS LOOSE AND MIGRATED. THIS EVENT WAS SOLVED BY ANOTHER ARTHROSCOPY ON (B)(6) 2025 AND THE SURGEON HAD TO REMOVE THE IMPLANT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23206572 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A ROTATOR CUFF REPAIR WITH BIOINDUCTIVE IMPLANT, THE PATIENT WAS SHOWING SING OF A INFLAMMATORY RESPONSE WITH FLUID AND PAINFUL SURGICAL SITE AFTER 2 TO 3 WEEKS OF THE PROCEDURE. THE PATIENT RECEIVED TREATMENT AT ER TUESDAY AUGUST 5TH AND WAS NOTED OF LARGE AMOUNTS OF CLEAR FLUID AND THE PRESENCE OF ¿SNOWFLAKES¿. LABS ARE AND NO INFECTION WAS PRESENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body Reaction; Inflammation

  MAUDE report 22894351 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A ROTATOR CUFF REPAIR WITH BIOINDUCTIVE IMPLANT, THE PATIENT BEGAN SHOWING SYMPTOMS ON AUGUST 7. AN IRRIGATION AND DEBRIDEMENT OF THE SURGICAL SITE WAS PERFORMED ON AUGUST 8. THE PATIENT EXHIBITED AN INFLAMMATORY RESPONSE WITH FLUID DEVELOPMENT IN THE SUBACROMIAL SPACE, FOLLOWED BY REMOVAL OF THE LATERAL ASPECT OF THE BIOINDUCTIVE IMPLANT. THE MEDIAL SIDE OF THE BIOINDUCTIVE IMPLANT APPEARED NORMAL AND WELL-INTEGRATED WITHIN THE FIRST 3 TO 5 MM. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body Reaction; Inflammation

  MAUDE report 22894330 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A ROTATOR CUFF REPAIR WITH BIOINDUCTIVE IMPLANT, THE PATIENT WAS SHOWING SIGNS OF AN INFLAMMATORY RESPONSE, WITH FLUID AND A PAINFUL SURGICAL SITE. AN IRRIGATION AND DEBRIDEMENT OF THE SURGICAL SITE WAS SCHEDULED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body Reaction; Inflammation

  MAUDE report 22894304 ↗
• InjuryDec 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN ARTHROSCOPY, THE DOCTOR WAS WORRIED THAT THE REGENETEN IMPLANT CAUSED SIDE EFFECTS. THE PATIENT PRESENTED TO THE CLINIC WITH DISCOMFORT SWELLING AND SHOULDER PAIN. A MULTIPLANAR MULTISEQUENCE MRI WITHOUT CONTRAST WAS MADE ON THE RIGHT SHOULDER. THE RESULTS SHOWED THAT THERE WAS LARGE AMOUNT OF FLUID IN THE SUB ACROMIAL SUBDELTOID BURSA, COMPLEX FLUID WITH INTERNAL AREAS OF LINEAR SYNOVIAL THICKENING. THE COMPLEX FLUID EXTENDS THROUGH A DEFECT OR WIDENING ACROSS THE ACROMIOCLAVICULAR JOINT INTO THE ADJACENT SOFT TISSUES OF THE CRANIAL MARGIN OR THE ACROMIOCLAVICULAR JOINT WITH A LARGE FLUID COLLECTION WITH NODULAR THICKENED AREAS. THIS MAY REPRESENT COMPLEX SUBACROMIAL SUBDELTOID BURSITIS WHICH WAS DECOMPRESSED INTO THE ACROMIAL CLAVICULAR JOINT WITH DECOMPRESSION INTO THE CRANIAL SOFT TISSUES ACROSS THE ACROMIOCLAVICULAR JOINT. SUPRASPINATUS TENDINOSIS WITH ACUTE PARTIAL THICKNESS PARTIAL WIDTH LOW GRADE ARTICULAR SURFACE TEAR WITHOUT THE TENDON RETRACTION MUSCLE ATROPHY. INFRASPINATUS TENDINOSIS WITH ACUTE PARTIAL THICKNESS PARTIAL WIDTH LOW GRADE ARTICULAR SURFACE/INSERTIONAL TEAR WITHOUT TENDON RETRACTION MUSCLE ATROPHY OR EDEMA. IT IS UNKNOW HOW IT

  Patient problems: Bursitis; Muscle/Tendon Damage; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20875398 ↗
• MalfunctionNov 13, 2024Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOINDUCTIVE IMPLANT DID NOT UNRAVEL DURING THE ARTHROSCOPIC IMPLANTATION. WHEN THE DOCTOR PULLED THE DEPLOYMENT TRIGGER IT CAME OUT OF THE SHEATH BUT WAS STUCK ROLLED UP. ONCE THE IMPLANT WAS ABLE TO UNROLL WITH ADDITIONAL ASSISTANCE IT WAS USED. THE IMPLANT WAS USED PER INSTRUCTIONS. THERE WAS A DELAY GRATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678048 ↗
• MalfunctionFeb 23, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR, THE REGENETEN BIOINDUCTIVE METAL IMPLANT ARMS DISLODGED FROM DEPLOYMENT GUN INSIDE OF SHOULDER JOINT. IT WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE REPORTED DEVICE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18768770 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A REGENETEN IMPLANTATION PROCEDURE USING THE BIOINDUCTIVE IMPLANT IN 2022, THE PATIENT HAD RICE BODIES AND EXPERIENCED PAIN, A WASHOUT WAS PERFORMED ON (B)(6) 2023. THE CURRENT PATIENT STATUS IMPROVED SINCE WASHOUT.

  Patient problems: Foreign Body Reaction; Pain; Synovitis

  MAUDE report 18048544 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, APPROXIMATELY, A MONTH AND HALF AFTER AN ARTHROSCOPY WHERE A REGENETEN BIOINDUCTIVE IMPLANT WAS USED, A RAISED SACK APPEARED ON THE INTRA LATERAL PORTAL OF THE PATIENT. SYNOVIAL FLUID WAS DRAINING OUT OF THE SACK WITH SOME CHUNKS. WHEN THE SACK WAS DECOMPRESSED AND THEN ABDUCTED, PARTICLES COULD BE SEEN. IT IS UNKNOWN HOW THE INJURY WAS TREATED OR THE PATIENT'S OUTCOME.

  Patient problems: Cyst(s); Fluid Discharge; Swelling/ Edema

  MAUDE report 16950213 ↗
• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BIOINDUCTIVE IMPLANT GENERATED AN ADVERSE REACTION, AND CAUSED AN INFLAMMATORY RESPONSE WHEN USING IT. THE DEVICE WAS EXPLANTED THE SAME DAY. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Inflammation

  MAUDE report 16388338 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED AN INFLAMMATION 6 WEEKS AFTER A SURGERY WHERE 2 REGENETEN DEVICES WERE USED. THE PATIENT WAS BROUGHT BACK TO SURGERY AT 8 WEEKS, NO INFECTION WAS FOUND BUT THE DOCTOR FELT THE REGENETEN WAS ¿MUSHY¿ AND DECIDED TO REMOVE IT. HE WAS NOT SURE IF THERE WAS AN ISSUE WITH REGENETEN, BUT HE IS ALSO NOT SURE IT WAS INCORPORATING LIKE IT SHOULD. FIXATION COULD HAVE ALSO BEEN AN ISSUE AS THE DISTAL PART OF THE IMPLANT MAY NOT HAVE BEEN FIXATED WELL. NO ADDITIONAL COMPLICATIONS WERE REPORTED.

  Patient problems: Inflammation

  MAUDE report 15591584 ↗
• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER APPROXIMATELY 7 MONTHS OF A BURSAL TEAR REPAIR WITH REGENETEN, A REVISION SURGERY WAS PERFORMED DUE TO PATIENT REPORT OF WEAKNESS IN SHOULDER AND SOME SORT OF FEELING OF MECHANICAL GRINDING. SOME LOSE BODIES WERE REMOVED FROM THE PATIENT AND SENT FOR CULTURE/EXAMINATION. NO PLDLA STAPLES WERE VISIBLE. A BONE ANCHOR WAS IDENTIFIED LATERAL TO THE FOOTPRINT AND APPEARED TO BE FLUSH WITH THE HUMERUS.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 14399314 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 A ROTATOR CUFF REPAIR FOR BICEP TENODESIS WAS DONE USING REGENETEN. ON DAY 13 AFTER SURGERY, THE PATIENT RETURNED BACK WITH SWELLING AND SOME DISCHARGE FLUID FROM THE WOUND SITE. THE NEXT DAY, THE PATIENT WENT FOR AN EXPLORATION SURGERY, IT WAS FOUND PUS, AND A LOT OF SERIOUS FLUIDS WERE SEEN. A CULTURE SWAB TEST WAS DONE, AND THE RESULT WAS NEGATIVE AND THE TOTAL WHITE BLOOD CELL WAS NORMAL, WITH ONLY CRP RISE. TWO DAYS LATER, A VAC MACHINE WAS APPLIED TO THE WOUND, NOT MUCH DISCHARGE WAS SEEN. ON (B)(6) 2022, THE PATIENT WENT BACK FOR CLOSURE OF THE WOUND. HOWEVER, A LOT OF DISCHARGE AND WHITISH MATERIAL WAS SEEN FLOWING OUT FROM THE WOUND SITE. IT SEEMS LIKE THE REGENETEN WAS BROKEN DOWN INTO PIECES. THERE WAS A SMALL BRIDGE SEEN IN THE DELTOID TOO. THE SURGEON SPLIT THE DELTOID AND SAW A LOT OF WHITISH MATERIAL INSIDE. THE REPAIR FOR THE ROTATOR CUFF WAS SOLID AND STABLE. NO SIGN OF REGENETEN MERGING TO THE REPAIR. THE SURGEON SUSPECTED THAT MIGHT BE A HYPERSENSITIVE REACTION TO REGENETEN IMPLANT. ON (B)(6) 2022, THE PATIENT UNDERWENT ANOTHER WASHOUT PROCEDURE, AND NO DISCHARGE WAS SEEN AFTER THAT DATE. GENERAL INFLAMMATION WAS SEEN IN THE SU

  Patient problems: Fluid Discharge; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 13937896 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER APPROXIMATELY FOUR MONTHS OF AN ACHILLES REPAIR PROCEDURE WITH REGENETEN, A PATIENT HAD SEVERE PAIN AND SWELLING OF THE ACHILLES AREA. A CT SHOWED AN ABSCESS WITHIN THE ACHILLES TENDON SO AN INCISION WAS MADE TO DEBRIDE THE AREA. THE CULTURES SHOWED A MSSA INFECTION. THE PATIENT WAS TREATED AND THE INFECTION WAS RESOLVED.

  Patient problems: Abscess; Bacterial Infection; Pain; Swelling/ Edema

  MAUDE report 13529302 ↗
• MalfunctionSep 28, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A ROTATOR PROCEDURE, THE SIZE OF THE BIOINDUCTIVE IMPLANT WAS WRONG; THE REGENETEN BIOINDUCTIVE IMPLANT LOOKED AND SEEMED TO BE LABELED WRONG REGARDING THE SIZE. THE SURGEON OPENED THE BOX LABELED ¿LARGE¿. IT DID NOT COVER THE TYPICAL AREA THAT IT NORMALLY DOES. AFTER IT WAS IMPLANTED THE SURGEON NEEDED ANOTHER ONE TO COVER THE SPACE THAT IT NORMALLY WOULD COVER. ANOTHER ¿LARGE¿ OF THE SAME LOT NUMBER WAS USED, HOWEVER IT SEEMED TO BE MUCH LARGER AND THE ACCURATE SIZE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12543310 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, APPROX.. 6 MONTHS POST-OPERATION, THE PATIENT RETURNED TO THE CLINIC REPORTING PAIN AND INFLAMMATION. THE PATIENT SAID A MATTRESS HOT HIS SHOULDER. THE MRIS SHOWED INFLAMMATION AND THE PRESENCE OF RICE BODIES AROUND THE REPAIR SITE. A RECENT MRI LOOKED GOOD AND NORMAL, RICE BODIES AND INFLAMMATION WERE GONE. PATIENT HAD AN INFECTION AND RECOVERED FOLLOWING ANTIBIOTICS. NO FOLLOW-UP SURGERY/WASHOUT WAS SCHEDULED.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 11823502 ↗
• InjuryMar 14, 2021Break; Break

  IT WAS REPORTED THAT THE REGENETEN BIOINDUCTIVE IMPLANT "SCAFFOLD" WAS USED ON A PATELLA TENDON REVISION. THE IMPLANT WAS SUTURED ON THE TOP OF THE REPAIR AND NO STAPLES WERE USED. THREE MONTHS AFTER THE OPERATION, A WASH OUT WAS PREFORMED BECAUSE THE PATIENT DEVELOPED A RECALCITRANT PRE-PATELLAR BURSITIS. THE DOCTOR ASPIRATED MANY TIMES AND A MILKY FLUID CAME OUT. THE CULTURES WERE NEGATIVE. THE DOCTOR BELIEVES THAT THE INFLAMMATORY REACTION HAPPENED DUE TO THE SCAFFOLD BREAKING DOWN. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Fluid Discharge; Inflammation

  MAUDE report 11478734 ↗
• InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON IMPLANTED A REGENETEN LARGE BIOINDUCTIVE IMPLANT ON (B)(6). AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF PAIN AND SORENESS FROM THE POST OP INCISION SITE. THE SURGEON WENT BACK IN TO DO A WASHOUT ON (B)(6) 2020. THE CURRENT PATIENT STATUS IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Pain

  MAUDE report 11347625 ↗
• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON IMPLANTED THE REGENETEN LARGE BIO-INDUCTIVE IMPLANT IN THE PRIMARY CASE ON (B)(6) 2020. AFTER THE PROCEDURE, THE SURGEON HAD TO BRING PATIENT BACK FOR WASHOUT BECAUSE COMPLAINING OF PAIN AND DISCHARGE FROM THE WOUND. THE IMPLANT WAS REMOVED BY THE SHAVER IN THE SECOND SURGERY. THE CURRENT PATIENT STATUS IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Pain

  MAUDE report 11342265 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ROTATOR CUFF REPAIR 7 WEEKS AGO AND WAS AUGMENTED WITH REGENETEN BIOINDUCTIVE IMPLANT. THE PATIENT STARTED EXPERIENCING IRRITATION AND INFLAMMATION. SURGEON SCOPED THE SHOULDER AND FOUND A FULLY INTACT BIOINDUCTIVE IMPLANT AS WELL AS WHITE RISOTTO LIKE SUBSTANCE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11135550 ↗
• InjuryDec 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE BIOINDUCTIVE IMPLANT WAS IMPLANTED, THE PATIENT INCISION WAS BUBBLING, BLISTERING AND DRAINING. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Blister

  MAUDE report 10932867 ↗
• InjuryDec 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER 5 DAYS FROM THE BIOINDUCTIVE IMPLANT WAS IMPLANTED, THE PATIENT INCISION WAS BUBBLING, BLISTERING AND DRAINING. IT WAS PERFORMED AN IRRIGATION, DEBRIDEMENT AND THE IMPLANT WAS REMOVED. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Blister

  MAUDE report 10932381 ↗
• InjuryJun 2, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT WHEN DEPLOYING THE LARGE REGENETEN, IT SEEMED TO BE LOADED UPSIDE DOWN. THE BLUE BORDER WAS ON TOP BUT NO METAL FEET TO KEEP IT IN PLACE WAS SEEN ON THE TOP SIDE. THE CUSTOMER IS NOT SURE IF IT WAS A FLUKE OR IF SOME HOW IT HAPPENED AS THEY ROCKED THE DEVICE BACK AND FORTH FOR IT TO FULLY OPEN UP. IT WAS REMOVED BY PULLING OUT THE DEPLOYMENT DEVICE AND A NEW ONE WAS OPENED. NO FURTHER INFORMATION RELATED WITH THE PATIENT IS AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10112899 ↗