PRIMATRIX MESHED 2 X 2CM
Report
- Report Number
- 3004170064-2024-00003
- Event Type
- Death
- Date Received
- January 17, 2024
- Date of Event
- March 5, 2020
- Report Date
- July 12, 2024
- Manufacturer
- TEI BIOSCIENCES INC
- Product Code
- KGN
- PMA / PMN Number
- K153690
- Removal / Correction Number
- 3004170064-05/23/2023-00
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
THE PRIMATRIX (ID 607-005-220) WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED. DUE TO THE REPORTED DEATH, A MEDICAL ASSESSMENT WAS REQUESTED BY THE MEDIAL SAFETY DEPARTMENT AND THE FOLLOWING WAS CONCLUDED: THERE IS NO INDICATION THAT THE PRIMATRIX WAS AT ALL RELATED TO THE DEATH OF THE PATIENT AFTER A SMALL 2CMX2CM GRAFT WAS APPLIED APPROXIMATELY 20 MONTHS PRIOR TO THE DEATH OF THE PATIENT WHO PRESENTED WITH MULTIPLE WOUNDS AND NO FEVER AT THE TIME OF DEHISCENCE.
UPDATED FIELDS: G3, G6, H2, H9, H10 FOLLOW-UP TO INCLUDE CORRECTION/REMOVAL NUMBER (H9) AND RELATED REPORT NUMBER (H10).
ADDITIONAL INFORMATION RECEIVED: QUESTION: FOR OUR DOCUMENTATION, CAN YOU PLEASE ADVISE WHY THERE WAS A DELAY IN SUBMITTING THE MEDWATCH FORMS FOR THE VARIOUS PRIMATRIX COMPLAINTS REPORTED IN NOVEMBER OF 2023. SOME COMPLAINTS DATE BACK AS FAR AS 2019, BUT ALL COMPLAINTS WERE REPORTED AT THE SAME TIME IN NOVEMBER 2023. WAS THIS DUE TO THE RECALL? ANSWER: "YES. THIS WAS DUE TO THE INTEGRA RECALL." - FDA RECALL NUMBER: (B)(4).
ADDITIONAL INFORMATION RECEIVED: PLACEMENT DATE: ON (B)(6) 2020. GRAFT FAILURE: (UNSURE - COULD HAVE JUST BEEN NON-HEALING WOUND). GRAFT FAILURE DATE: ON (B)(6) 2020. PATIENT HEALTH EFFECT AND HEALTH EFFECT DATE: WOUND DEHISCENCE, INCREASED DRAINAGE CAUSE OF DEATH: LEFT BELOW KNEE AMPUTATION (BKA) NECROSIS; CARDIAC ARREST- UNRELATED. DATE OF DEATH: ON (B)(6) 2021.
MEDWATCH # MW5148668. "(B)(6) DEHISCENCE OF AMPUTATION WOUND- LEFT LATERAL FOOT. CHRONIC ULCER OF TOES RIGHT. PRIMATRIX APPLIED TO LEFT FOOT WOUND. (B)(6) LEFT 4TH AND 5TH AMPUTATION SITE- FULLY DEHISCED- GRAFT REMOVED TODAY INCREASED WITH ODOR AND DISCOLORATION. DEBRIDEMENT. NO PRIMATRIX UTILIZED. (B)(6) SMALL DRAINAGE NO PRIMATRIX WAS APPLIED ON (B)(6) THEN THE PATIENT RETURNED WITH INCREASED DRAINAGE. NO FURTHER PRIMATRIX UTILIZED." ADDITIONAL INFORMATION RECEIVED: PRIMATRIX PLACEMENT DATE: A. PLACED (B)(6) 2020. B. AFTER INFORMED CONSENT, THE ULCER WAS CLEANED FOR PRIMATRIX PLACEMENT. C. THE WOUND BED WAS PREPPED AS DESCRIBED IN THE PRIMATRIX PROTOCOLS. D. NO ANESTHESIA WAS USED. E. PRIMATRIX WAS HYDRATED AND PREPARED AS PER MANUFACTURER INSTRUCTIONS. THE PRIMATRIX WAS TRIMMED TO SIZE AND PLACED INTO THE ULCER GIVING 100% COVERAGE OF THE ULCER. IT WAS SECURED IN PLACE WITH WOUND VEIL AND STERISTRIPS. F . PATIENT TOLERATED PROCEDURE WELL. NO COMPLICATIONS. BLOOD LOSS WAS MINIMAL. G. GRAFT SIZE: 2CM X 2CM. H. GRAFT LOT#: 1903054, EXPIRATION DATE: 2023-11-30. I. SALINE LOT#: 9205544, EXPIRATION DATE: 2022-09-31. J. TOTAL AMOUNT OF GRAFT USED: 100%. K. TOTAL AMOUNT OF GRAFT WASTED: 0%. - PATIENT AGE AND GENDER: 63 YEAR OLD FEMALE. - PATIENT RACE AND ETHNICITY: AFRICAN AMERICAN/NON HISPANIC. - DID THE PATIENT PRESENTED WITH SIGNS OF INFECTION? (E.G FEVER) NO FEVER DOCUMENTED. - PLEASE CONFIRM REASON FOR WOUND DEHISCENCE. UNSURE OF REASON WHY PATIENT HAD DEHISCENCE. PATIENT HAD MULTIPLE WOUNDS. - TREATMENT FOR WOUND DEHISCENCE. CLEANSED WITH VASHE AND 4 X 4'S. APPLIED IODOFLEX TO WOUNDS OF LEFT 3RD, 4TH, AND 5TH TOES. COVERED WITH 4 X 4'S. WRAPPED WITH KERLIX AND SECURED WITH TAPE. APPLIED VASHE WET TO DRY TO RIGHT FOOT AMPUTATION SITE. COVERED WITH 4 X 4'S. WRAPPED WITH KERLIX AND SECURED WITH TAPE. - CURRENT STATUS OF THE PATIENT. PATIENT IS CURRENTLY DECEASED.
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Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 511110 | PRIMATRIX MESHED 2 X 2CM | PRIMATRIX | KGN | TEI BIOSCIENCES INC | 1903054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female | Death |