TYRX™ Absorbable Antibacterial Envelope - Medium CMRM6122Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169468856), received between Apr 10, 2017 and Apr 26, 2018 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Shelf Life Exceeded” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY EIGHT DAYS POST IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG) THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH REDNESS, SWELLING, PAIN, AND ERYTHEMA AT THE INCISION SITE. A POST-OPERATIVE INFECTED SEROMA WAS NOTED. A BEDSIDE ULTRASOUND REVEALED A COLLECTION OF FLUID AT THE LATERAL SIDE OF THE INCISION AND ASPIRATION OF ¿BROWNISH FLUID¿ WAS PERFORMED. TWO DAYS LATER THE PATIENT PRESENTED TO THE EMERGENCY ROOM AND EXTENSION OF REDNESS AROUND THE INCISION SITE WAS NOTED. WHEN THE MEDIAL CORNER OF THE SITE WAS ¿PUSHED DOWN¿ THERE WAS DISCHARGE OF SANGUINOUS FLUID NOTED TO BE CONCERNING FOR HEMATOMA AND POSSIBLE INFECTION. ADDITIONALLY, THE REDNESS WAS ¿TRACKING DOWN TO THE BREAST AREA.¿ THE PATIENT WAS ADMITTED AND PLACED ON INTRAVENOUS ANTIBIOTIC TREATMENT. FOLLOWING, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR TREATMENT OF AN EXTENSIVE INFECTION OF THE POCKET AND SURROUNDING TISSUE. THE IPG SYSTEM WAS REMOVED, WIDE EXCISIONAL DEBRIDEMENT OF THE LEFT CHEST WOUND, EXCISION OF SKIN, SUBCUTANEOUS TISSUE AND PECTORALIS MAJOR MUSCLE WAS PERFORMED. THE PATIENT WAS PLACED ON A TEMPORARY PACING SYSTEM, WOUND VACUUM ASSISTED CLOSURE PLACEMENT,

  Patient problems: Burning Sensation; Cellulitis; Endocarditis; Erythema; Fever; Fungal Infection; Gangrene; Hematoma; Impaired Healing; Necrosis; Pain; Rash; Seroma; Swelling; Unspecified Infection

  MAUDE report 7467027 ↗
• MalfunctionFeb 8, 2018Shelf Life Exceeded; Shelf Life Exceeded

  IT WAS REPORTED THAT THE ABSORBABLE ANTIBACTERIAL ENVELOPE WAS IMPLANTED AFTER THE USE BEFORE DATE. THE ENVELOPE REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7256443 ↗
• InjuryAug 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION WITH THEIR IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER INFORMATION COULD BE OBTAINED THROUGH FOLLOW-UP. THE DEVICE REMAINS IN USE. THE PATIENT ALSO WAS NOTED TO HAVE AN ANTIBIOTIC ENVELOPE WITH THE DEVICE. THE PATIENT IS A PARTICIPANT IN THE (B)(6) CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 6786766 ↗
• InjuryAug 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INFECTION OCCURRED. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND A TEMPORARY PACING SYSTEM WAS IMPLANTED UNTIL THE SYSTEM CAN BE REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 6783024 ↗
• InjuryJun 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM, A POCKET REVISION AND IMPLANT OF AN ABSORBABLE ANTIBACTERIAL ENVELOPE WAS PERFORMED DUE TO EXCORIATION AND MEDIAL EDGE OF POCKET INCISION FAILED TO HEAL WITH NON-UNION. AT CLINIC FOLLOW UP THE IPG SITE WAS NOT HEALING AND A HEMATOMA WAS NOTED ALONG WITH AN OPENING IN THE INCISION. IT WAS FURTHER REPORTED THAT INFECTION WAS SUSPECTED. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma; Impaired Healing; Unspecified Infection

  MAUDE report 6625282 ↗
• InjuryApr 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN IMPLANT SITE INFECTION LIMITED TO CELLULITIS APPROXIMATELY THREE WEEKS AFTER THE IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG) WITH ABSORBABLE ENVELOPE. THE PATIENT CALLED THEIR PHYSICIAN'S OFFICE AND COMPLAINED OF DRAINAGE AT THE INCISION SITE. THE PATIENT WAS INSTRUCTED TO GO TO THE EMERGENCY DEPARTMENT (ED) FOR EVALUATION. THE PATIENT STATED THE ED PHYSICIAN SAID THE INCISION DID NOT LOOK INFECTED AND SENT THE PATIENT HOME. A WEEK LATER THE PATIENT CALLED THEIR PHYSICIAN'S OFFICE AGAIN REGARDING CLEAR FLUID DRAINING. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN IMPLANTED AND IN USE. THE PATIENT IS A PARTICIPANT IN THE (B)(6) STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 6477933 ↗