STRATAFIX SXPP1A443Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10705031245280), received between Jul 20, 2019 and Apr 3, 2026 — classified as 16 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 38 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAMINECTOMY/FUSION PROCEDURE ON (B)(6) 2026 AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED AN INFECTION AND DEHISCENCE. WHEN THE SURGEON WENT TO REOPEN THE INCISION, HE FOUND THAT THE SUTURE HAD ESSENTIALLY COMPLETELY DISSOLVED AND WAS SUPER FRAGILE WITHIN A MONTH, UNDER THE AVERAGE AMOUNT OF TIME THE SUTURE HOLDS STRENGTH FOR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 24776693 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANNICULECTOMY PROCEDURE ON (B)(6) 2026 DUE TO EXCESSIVE PANNICULUS AND INTERTRIGO CANDIDIASIS AND BARBED SUTURE WAS USED ON THE FASCIA. POST-OP, THE PATIENT EXPERIENCED A SUBCLINICAL HEMATOMA. THE PATIENT WENT HOME POST OP DAY 1, REMOVED DRAIN, SKIN DIED FOLLOWING WEEK. THE SKIN DIED, ON POST OP DAY 10 THE PATIENT CAME TO ER AND UNDERWENT WOUND DEBRIDEMENT. THE SUTURE BEGAN BREAKING DOWN DURING THE SECOND PROCEDURE. THE PATIENT HAS RECOVERED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Necrosis

  MAUDE report 24400372 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANNICULECTOMY PROCEDURE ON (B)(6) 2026 DUE TO INTERTRIGO CANDIDIASIS AND BARBED SUTURE WAS USED ON THE FASCIA. POST-OP, THE PATIENT EXPERIENCED A HEMATOMA/HEMORRHAGE. THE PATIENT WAS GIVEN A BLOOD TRANSFUSION ON POST OP DAY 1 AND DEVELOPED RAPID RESPONSE HYPERTENSION AND WAS TRANSFERRED TO STEP DOWN. THE PATIENT HAS RECOVERED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension

  MAUDE report 24400369 ↗
• MalfunctionDec 11, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING AN UNKNOWN OPEN SURGERY AND WOUND CLOSURE, THE NEEDLE TIP WAS BROKEN, BUT THE NEEDLE TIP COULD ALSO BE RETRIEVED WITHOUT REMAINING NO PIECES IN THE PATIENT¿S BODY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778267 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANNICULECTOMY PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED SKIN NECROSIS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Necrosis; Wound Dehiscence

  MAUDE report 23425588 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY UNDERWENT A KNEE SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. THE PATIENT STATED THEY WERE ALLERGIC TO SOMETHING AND HAVING ALLERGY TESTING. ON (B)(6) 2025, THE PATIENT HAD SWELLING AND COULD NOT PUT WEIGHT ON IT. THE PATIENT STATED THEY MAY BE ALLERGIC TO NICKEL. THE SURGEON STATED THE PATIENT HAD A REACTION AND TOOK CARE OF IT WITH ANTIBIOTIC. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Impaired Healing; Swelling/ Edema

  MAUDE report 23309355 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY UNDERWENT AN EYE SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. THE PATIENT STATED THEY WERE ALLERGIC TO SOMETHING, STITCH IN EYE HAVING ISSUES AND HAVING ALLERGY TESTING. ON JUNE 24TH, THE PATIENT HAD SWELLING AND COULD NOT PUT WEIGHT ON IT. THE PATIENT STATED THEY MAY BE ALLERGIC TO NICKEL. THE EYE SURGEON STATED THE PATIENT HAD A REACTION AND TOOK CARE OF IT WITH ANTIBIOTIC. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 23309349 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED IN THE DEEP FASCIA LAYER. THE SURGEON SAID THE PATIENT GOT AN INFECTION AFTERWARDS. WHEN HE REMOVED THE SUTURE PUS WAS COMING OUT FROM THE AREA WHERE THE BARBED SUTURE WAS LOCATED. THE SURGEON IS CONVINCED IT WAS BECAUSE IT WAS OF THE BARBED SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 21332954 ↗
• MalfunctionDec 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE IN (B)(4) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORM, #(B)(4), DURING TOTAL KNEE ARTHROPLASTY; NEEDLE POPPED OFF SUTURE DURING USE FOR WOUND CLOSURE. NEEDLE WAS SECURED AND SET ASIDE. NEW SUTURE NEEDLE OBTAINED; SAME THING HAPPENED. ONCE MORE A NEW SUTURE NEEDLE WAS OBTAINED WITH THE SAME RESULT. THERE WAS NO PATIENT CONSEQUENCES REPORTED. DEVICE AVAILABILITY UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21020385 ↗
• MalfunctionDec 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE IN (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORM, #(B)(4), DURING TOTAL KNEE ARTHROPLASTY; NEEDLE POPPED OFF SUTURE DURING USE FOR WOUND CLOSURE. NEEDLE WAS SECURED AND SET ASIDE. NEW SUTURE NEEDLE OBTAINED; SAME THING HAPPENED. ONCE MORE A NEW SUTURE NEEDLE WAS OBTAINED WITH THE SAME RESULT. THERE WAS NO PATIENT CONSEQUENCES REPORTED. DEVICE AVAILABILITY UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21020382 ↗
• MalfunctionDec 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE IN (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORM, # (B)(4), DURING TOTAL KNEE ARTHROPLASTY; NEEDLE POPPED OFF SUTURE DURING USE FOR WOUND CLOSURE. NEEDLE WAS SECURED AND SET ASIDE. NEW SUTURE NEEDLE OBTAINED; SAME THING HAPPENED. ONCE MORE A NEW SUTURE NEEDLE WAS OBTAINED WITH THE SAME RESULT. THERE WAS NO PATIENT CONSEQUENCES REPORTED. DEVICE AVAILABILITY UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21020380 ↗
• MalfunctionOct 28, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURE CAME OFF THE NEEDLE WHILE SUTURING UNKNOWN TISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20550138 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, X2 SNAPPED SUTURE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981376 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON (B)(6)2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, X2 SNAPPED SUTURE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981373 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6)2024 AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED A DISLOCATED PATELLA POST OPERATIVELY. THE DISLOCATION WAS DISCOVERED BETWEEN 5 WEEKS POST OP AND 8 WEEK POST OP (35 DAY/ 56 DAY). THE PATIENT WAS TAKEN TO SURGERY FOR VMO REPAIR/ ADVANCEMENT AND MAY HAVE HAD A LATERAL RELEASE DEPENDING ON TRACKING OF THE PATELLA. REPAIR WAS DONE WITH INTERRUPTED NON ABSORBABLE SUTURE AS WELL AS A CONTINUOUS NON ABSORBABLE 1 V LOC AND THE PATIENT DID NOT HAVE A REOCCURRENCE OF DISLOCATING PATELLA FOLLOWING THE REPAIR. WHEN THE EXPOSURE WAS MADE THE ABSORBABLE SUTURE WAS COMPLETELY GONE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Joint Dislocation

  MAUDE report 19265891 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED A DISLOCATED PATELLA POST OPERATIVELY. THE DISLOCATION WAS DISCOVERED BETWEEN 5 WEEKS POST OP AND 8 WEEK POST OP (35 DAY/ 56 DAY). THE PATIENT WAS TAKEN TO SURGERY FOR VMO REPAIR/ ADVANCEMENT AND MAY HAVE HAD A LATERAL RELEASE DEPENDING ON TRACKING OF THE PATELLA. REPAIR WAS DONE WITH INTERRUPTED NON ABSORBABLE SUTURE AS WELL AS A CONTINUOUS NON ABSORBABLE 1 V LOC AND THE PATIENT DID NOT HAVE A REOCCURRENCE OF DISLOCATING PATELLA FOLLOWING THE REPAIR. WHEN THE EXPOSURE WAS MADE THE ABSORBABLE SUTURE WAS COMPLETELY GONE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Joint Dislocation

  MAUDE report 19265888 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED A DISLOCATED PATELLA POST OPERATIVELY. THE DISLOCATION WAS DISCOVERED BETWEEN 5 WEEKS POST OP AND 8 WEEK POST OP (35 DAY/ 56 DAY). THE PATIENT WAS TAKEN TO SURGERY FOR VMO REPAIR/ ADVANCEMENT AND MAY HAVE HAD A LATERAL RELEASE DEPENDING ON TRACKING OF THE PATELLA. REPAIR WAS DONE WITH INTERRUPTED NON ABSORBABLE SUTURE AS WELL AS A CONTINUOUS NON ABSORBABLE 1 V LOC AND THE PATIENT DID NOT HAVE A REOCCURRENCE OF DISLOCATING PATELLA FOLLOWING THE REPAIR. WHEN THE EXPOSURE WAS MADE THE ABSORBABLE SUTURE WAS COMPLETELY GONE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Joint Dislocation

  MAUDE report 19265887 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON 19(B)(6) 2023 AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED A DISLOCATED PATELLA POST OPERATIVELY. THE DISLOCATION WAS DISCOVERED BETWEEN 5 WEEKS POST OP AND 8 WEEK POST OP (35 DAY/ 56 DAY). THE PATIENT WAS TAKEN TO SURGERY FOR VMO REPAIR/ ADVANCEMENT AND MAY HAVE HAD A LATERAL RELEASE DEPENDING ON TRACKING OF THE PATELLA. REPAIR WAS DONE WITH INTERRUPTED NON ABSORBABLE SUTURE AS WELL AS A CONTINUOUS NON ABSORBABLE 1 V LOC AND THE PATIENT DID NOT HAVE A REOCCURRENCE OF DISLOCATING PATELLA FOLLOWING THE REPAIR. WHEN THE EXPOSURE WAS MADE THE ABSORBABLE SUTURE WAS COMPLETELY GONE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Joint Dislocation

  MAUDE report 19265886 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED A DISLOCATED PATELLA POST OPERATIVELY. THE DISLOCATION WAS DISCOVERED BETWEEN 5 WEEKS POST OP AND 8 WEEK POST OP (35 DAY/ 56 DAY). THE PATIENT WAS TAKEN TO SURGERY FOR VMO REPAIR/ ADVANCEMENT AND MAY HAVE HAD A LATERAL RELEASE DEPENDING ON TRACKING OF THE PATELLA. REPAIR WAS DONE WITH INTERRUPTED NON ABSORBABLE SUTURE AS WELL AS A CONTINUOUS NON ABSORBABLE 1 V LOC AND THE PATIENT DID NOT HAVE A REOCCURRENCE OF DISLOCATING PATELLA FOLLOWING THE REPAIR. WHEN THE EXPOSURE WAS MADE THE ABSORBABLE SUTURE WAS COMPLETELY GONE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Joint Dislocation

  MAUDE report 19265885 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6)2023 AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED A DISLOCATED PATELLA POST OPERATIVELY. THE DISLOCATION WAS DISCOVERED BETWEEN 5 WEEKS POST OP AND 8 WEEK POST OP (35 DAY/ 56 DAY). THE PATIENT WAS TAKEN TO SURGERY FOR VMO REPAIR/ ADVANCEMENT AND MAY HAVE HAD A LATERAL RELEASE DEPENDING ON TRACKING OF THE PATELLA. REPAIR WAS DONE WITH INTERRUPTED NON ABSORBABLE SUTURE AS WELL AS A CONTINUOUS NON ABSORBABLE 1 V LOC AND THE PATIENT DID NOT HAVE A REOCCURRENCE OF DISLOCATING PATELLA FOLLOWING THE REPAIR. WHEN THE EXPOSURE WAS MADE THE ABSORBABLE SUTURE WAS COMPLETELY GONE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Joint Dislocation

  MAUDE report 19265884 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED A DISLOCATED PATELLA POST OPERATIVELY. THE DISLOCATION WAS DISCOVERED BETWEEN 5 WEEKS POST OP AND 8 WEEK POST OP (35 DAY/ 56 DAY). THE PATIENT WAS TAKEN TO SURGERY FOR VMO REPAIR/ ADVANCEMENT AND MAY HAVE HAD A LATERAL RELEASE DEPENDING ON TRACKING OF THE PATELLA. REPAIR WAS DONE WITH INTERRUPTED NON ABSORBABLE SUTURE AS WELL AS A CONTINUOUS NON ABSORBABLE 1 V LOC AND THE PATIENT DID NOT HAVE A REOCCURRENCE OF DISLOCATING PATELLA FOLLOWING THE REPAIR. WHEN THE EXPOSURE WAS MADE THE ABSORBABLE SUTURE WAS COMPLETELY GONE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Joint Dislocation

  MAUDE report 19265883 ↗
• MalfunctionMar 12, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ABDOMINAL HYSTERECTOMY ON AN UNKNOWN DATE IN 2024, AND BARBED SUTURE WAS USED. DURING THE SURGERY, A PDS STRATAFIX SYMMETRIC BROKE CLOSE TO THE SWAGE. THERE WAS NO PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884836 ↗
• MalfunctionJul 21, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING SURGERY, THE SURGEON APPLIED A STITCH ON MUSCULAR LAYER DURING WOUND CLOSURE, THE NEEDLE WAS DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. SUTURE METHOD WAS CONTINUOUS SUTURE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17372590 ↗
• MalfunctionApr 6, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CLOSING KNEE JOINT CAPSULE PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURE RIPPED OUT ONE TO TWO MONTHS AFTER SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691809 ↗
• MalfunctionMar 23, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN GYNECOLOGICAL PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING FACIA CLOSURE, THE FIXATION PAD WAS RIPPING THROUGH THE FACIA. SURGEON TRIED A SECOND TIME WITH THE SAME SUTURE STRAND WITH THE SAME OUTCOME. A COMPETITOR¿S SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600249 ↗