TYRX™ Absorbable Antibacterial Envelope - Large CMRM6133Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00643169468795), received between Apr 6, 2017 and Jun 13, 2019 — classified as 22 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Expiration Issue” (3 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED DUE TO AN INFECTION. THE PATIENT WAS HAVING AN UPGRADE PROCEDURE FROM AN IPG TO AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND WHEN THE PHYSICIAN OPENED THE POCKET, YELLOW DRAINAGE WAS NOTICED IN THE POCKET. CULTURES WERE TAKEN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD BEEN IMPLANTED WITH AN ABSORBABLE ENVELOPE. IT WAS ALSO FURTHER REPORTED THAT THE AEROBIC CULTURE TESTED POSITIVE FOR PROPIONIBACTERIUM ACNES.

  Patient problems: Unspecified Infection

  MAUDE report 8694706 ↗
• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT DEVELOPED A POCKET INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WAS REMOVED AND NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7617354 ↗
• InjuryMay 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AFTER IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WITH AN ABSORBABLE ENVELOPE. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE CRT-D REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE WORLD-WIDE RANDOMIZED ANTIBIOTIC ENVELOPE INFECTION PREVENTION TRIAL CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7483195 ↗
• InjuryApr 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE DAY AFTER THE IMPLANT PROCEDURE, THE PATIENT EXPERIENCED UNCONTROLLED PAIN AND A HEMATOMA AT THE DEVICE SITE. INITIALLY, THE PATIENT WAS GOING TO MONITOR THE SITE AND NO ANTIBIOTICS WERE PRESCRIBED, HOWEVER DUE TO CONTINUED BLEEDING, SWELLING, AND ECCHYMOSIS THAT EXTENDED INTO THE AXILLA, THE POCKET WAS RE-OPENED FOR EXPLORATION, THE HEMATOMA WAS EVACUATED, AND ANTIBIOTICS WERE STARTED FOR THE INFECTION. IT WAS LATER REPORTED THE DEVICE, RIGHT ATRIAL LEAD, AND RIGHT VENTRICULAR LEAD WERE EXPLANTED DUE TO THE INFECTION; THE LEFT VENTRICULAR LEAD WAS CAPPED. THE SYSTEM WAS LATER REPLACED. THE PATIENT WAS A PARTICIPANT IN THE (B)(6) TRIAL ((B)(6).) NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7464662 ↗
• InjuryMar 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION WITHIN ONE MONTH OF IMPLANTING THE ANTIBACTERIAL ENVELOPE. THE COMPETITOR PRODUCTS WERE REMOVED AND NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7374747 ↗
• InjuryMar 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD AN ALLERGIC REACTION TO THE ABSORBABLE ANTIBACTERIAL ENVELOPE. THE ENVELOPE WAS FOUND TO BE PARTIALLY ABSORBED AND THE "REMAINING PIECES WERE REMOVED." NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Reaction

  MAUDE report 7348623 ↗
• InjuryMar 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION APPROXIMATELY NINETEEN DAYS AFTER THE IMPLANT OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WITH AN ABSORBABLE ENVELOPE. THE ICD SYSTEM WAS EXTRACTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7342108 ↗
• MalfunctionMar 15, 2018Shelf Life Exceeded; Shelf Life Exceeded

  IT WAS REPORTED THAT AT THE ABSORBABLE ENVELOPE WAS IMPLANTED AFTER THE USE BEFORE DATE. THE ABSORBABLE 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 7341274 ↗
• MalfunctionFeb 8, 2018Device Expiration Issue; Device Expiration Issue

  IT WAS REPORTED THE ANTIBACTERIAL ENVELOPE WAS PLACED AND BEFORE THE POCKET WAS CLOSED IT WAS REALIZED THE ENVELOPE WAS PAST THE EXPIRATION DATE BY THREE DAYS. THE ENVELOPE WAS REMOVED AND A NEW ONE IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7257422 ↗
• MalfunctionFeb 8, 2018Device Expiration Issue; Device Expiration Issue

  IT WAS REPORTED THE ANTIBACTERIAL ENVELOPE WAS IMPLANTED ONE DAY PAST THE USE BY DATE. THE ENVELOPE REMAINS IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7256306 ↗
• InjuryFeb 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD GENERAL NECK SWELLING, DIFFICULTY BREATHING, AND POSSIBLE HYPERSENSITIVITY AFTER THEIR ABSORBABLE ANTIBACTERIAL ENVELOPE (AAE) WAS IMPLANTED, INTUBATION WAS NECESSARY. THE AAE WAS EXPLANTED AND REPLACED WITH A NEW AAE. APPROXIMATELY FIFTEEN MINUTES AFTER THE PATIENT'S POCKET WAS CLOSED THEY HAD GENERAL THROAT SWELLING AND SOME DIFFICULTY BREATHING. FIVE DAYS LATER, AFTER EVALUATION, THE SECOND AAE WAS EXPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED A HEMATOMA AFTER THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IMPLANTED. FOUR DAYS AFTER THE ICD WAS IMPLANTED, THE POCKET WAS REOPENED AND THE HEMATOMA WAS EVACUATED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Hypersensitivity/Allergic reaction; Swelling

  MAUDE report 7254381 ↗
• InjuryFeb 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD GENERAL NECK SWELLING, DIFFICULTY BREATHING, AND POSSIBLE HYPERSENSITIVITY AFTER THEIR ABSORBABLE ANTIBACTERIAL ENVELOPE (AAE) WAS IMPLANTED, INTUBATION WAS NECESSARY. THE AAE WAS EXPLANTED AND REPLACED WITH A NEW AAE. APPROXIMATELY FIFTEEN MINUTES AFTER THE PATIENT'S POCKET WAS CLOSED THEY HAD GENERAL THROAT SWELLING AND SOME DIFFICULTY BREATHING. FIVE DAYS LATER, AFTER EVALUATION, THE SECOND AAE WAS EXPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED A HEMATOMA AFTER THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IMPLANTED. FOUR DAYS AFTER THE ICD WAS IMPLANTED, THE POCKET WAS REOPENED AND THE HEMATOMA WAS EVACUATED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Hypersensitivity/Allergic reaction; Swelling

  MAUDE report 7254359 ↗
• InjuryFeb 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS REMOVED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7253950 ↗
• InjuryDec 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION. BLOOD CULTURES REVEALED THE ORGANISM RESPONSIBLE WAS ENTEROCOCCUS FAECALIS. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7093655 ↗
• MalfunctionDec 7, 2017Device Expiration Issue; Device Expiration Issue

  IT WAS REPORTED THE ANTIBACTERIAL ENVELOPE WAS IMPLANTED TWELVE DAYS PAST THE DATE OF EXPIRATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7093577 ↗
• InjuryOct 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A HEMATOMA. TEN CUBIC CENTIMETERS OF FLUID WAS ASPIRATED FROM THE POCKET. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 6920254 ↗
• InjuryOct 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT DEVELOPED A COAGULASE-NEGATIVE STAPHYLOCOCCI INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE IMPLANTABLE PULSE GENERATOR SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 6920022 ↗
• InjurySep 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EROSION WITH WOUND DEHISCENCE DUE TO A SUSPECTED INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXTRACTED. A DEBRIDEMENT OF THE SITE WAS PERFORMED AND A WOUND VAC WAS PLACED. THE SYSTEM WAS LATER REPLACED AFTER THE INFECTION RESOLVED. 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: Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 6876775 ↗
• InjuryAug 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT THOUGHT A STITCH MIGHT BE "POKING OUT OF THE OUTER LEFT SIDE OF THE INCISION AND THERE WAS REDNESS AND CLEAR/WHITE DRAINAGE." THE POCKET AREA WAS FOUND TO BE RED AND THERE WAS PURULENT DRAINAGE. IT WAS DETERMINED THE PATIENT DEVELOPED AN INFECTION/ACUTE CELLULITIS AND WAS TREATED WITH ANTIBIOTICS. APPROXIMATELY EIGHT DAYS LATER THE PATIENT WAS SEEN IN CLINIC AND THERE WERE NO SIGNS OR SYMPTOMS OF INFECTION. THE DEVICE REMAINS 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: Cellulitis; Purulent Discharge; Unspecified Infection

  MAUDE report 6783451 ↗
• InjuryAug 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT DEVELOPED A WOUND INFECTION. IT WAS ALSO REPORTED THE PATIENT PRESENTED WITH AN OPEN AREA ALONG THE LATERAL ASPECT OF THE DEVICE INSERTION SITE. THE AREA WAS APPROXIMATELY THE SIZE OF A DIME WITH A LIGHT BROWN CENTER AND THE SUTURE WAS VISIBLE. THE PATIENT WAS PLACED ON ORAL ANTIBIOTICS. SEVEN DAYS LATER THE PATIENT WAS SEEN AND IT WAS NOTED THERE WAS AN UNDISSOLVED SUTURE AT THE DISTAL INCISION AND THE AREA WAS SCABBED. THE PATIENT CONTINUED WITH THE ORAL ANTIBIOTIC COURSE FOR AN ADDITIONAL TEN DAYS. BLOOD CULTURES WERE NEGATIVE. THE PATIENT IS A PARTICIPANT IN THE (B)(6) CLINICAL STUDY. THE DEVICE REMAINS IN USE AND NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 6781397 ↗
• InjuryJun 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED AND ON X-RAY, LOOKED LIKE IT SLIGHTLY PULLED BACK. THE RV LEAD WAS FOUND TO HAVE DECREASED SENSITIVITY. DURING REPOSITIONING OF THE LEAD, THE PATIENT HAD A SMALL HEMATOMA IN THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE POCKET WHICH HAD A STERILE ANTIBACTERIAL ENVELOPE AROUND THE ICD. THE DEVICE POCKET WAS EVACUATED. THE PATIENT WAS NOTED TO HYPER RESPOND TO BLOOD THINNER USED DURING LEAD REPOSITIONING. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. THE ICD WITH ANTIBACTERIAL ENVELOPE REMAINED IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 6625194 ↗
• InjuryJun 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION WITH EROSION OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE POCKET WAS EVACUATED AND AN ABSORBABLE ANTIBACTERIAL ENVELOPE WAS IMPLANTED. APPROXIMATELY TWO MONTHS LATER, THE CRT-D BEGAN ERODING THROUGH THE SKIN AGAIN. THE CRT-D WAS EXTRACTED AND A SUBPECTORAL CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 6624485 ↗
• InjuryJun 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A POCKET INFECTION OCCURRED. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM AND ENVELOPE WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 6624061 ↗
• InjuryJun 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED DISLODGEMENT WITH NO CAPTURE AT MAXIMUM OUTPUTS. DURING THE LV LEAD RE VISION PROCEDURE, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POCKET WAS OPENED AND A PUS POCKET WAS OBSERVED WITH A POSSIBLE INFECTION. YELLOW AND SOME NECROTIC TISSUE WAS ALSO NOTED IN THE POCKET. THE ABSORBABLE ANTIBACTERIAL ENVELOPE WAS REMOVED AND REPLACED, ALONG WITH THE LV LEAD. THE CRT-D REMAINS IN USE AND THE PATIENT RECEIVED ANTIBIOTIC TREATMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 6623812 ↗
• InjuryApr 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN, REDNESS, CHILLS, WARMTH, AND PURULENT DRAINAGE AT THE SITE OF THE IMPLANT. THE PATIENT DEVELOPED A CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE INFECTION WITH THE ORGANISM BEING COAGULAR NEGATIVE STAPHYLOCOCCUS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT VENTRICULAR (RV) LEAD, RIGHT ATRIAL (RA) LEAD, AND ANTIBACTERIAL ENVELOPE WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chills; Pain; Unspecified Infection

  MAUDE report 6470727 ↗