PRIMATRIX FENESTRATED, 6X6 CM
Report
- Report Number
- 3004170064-2024-00008
- Event Type
- Malfunction
- Date Received
- January 17, 2024
- Date of Event
- June 27, 2019
- Report Date
- June 24, 2024
- Manufacturer
- TEI BIOSCIENCES INC
- Product Code
- KGN
- PMA / PMN Number
- K153690
- Removal / Correction Number
- 3004170064-05/23/2023-00
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION RECEIVED: PLACEMENT DATE (M/D/Y): (B)(6) 2019. PATIENT HEALTH EFFECT & DATE: MOIST LAYER OF GRAFT PRESENT IN SOME LOCATIONS. APPEARS TO BE HEALING. TREATMENT: (B)(6) 2019 - THERE IS A LARGE SKIN AND DEEP SOFT TISSUE DEFECT. DEEP TO THE MUSCLE/ TENDON. THE WOUND BED IS RED FOR THE MOST PART WITH AREA OF UNDERLYING DEEP TISSUE/FASCIA. TODAY THERE IS NO REMAINING GRAFT NOTED WITHIN THE WOUND BED IMPROVING GRANULATION TISSUE NOTED. (B)(6) 2019- CLEANSE WITH NORMAL SALINE AND GAUZE. PRIMATRIX SKIN GRAFT APPLICATION #3 WAS PLACED TODAY. COVERED WITH WOUND VEIL AND SECURED WITH STERI STRIPS. CALCIUM ALGINATE PLACED OVER RESTORE WOUND VEIL, FOLLOWED BY 4X4S AND WRAPPED WITH KERLIX. (B)(6) 2019- THERE IS A LARGE SKIN AND DEEP SOFT TISSUE DEFECT. -DEEP TO THE MUSCLE/ TENDON. TODAY THE WOUND BED HAD FILLED IN VERY WELL. (B)(6) 2019- THERE IS A LARGE SKIN AND DEEP SOFT TISSUE DEFECT. DEEP TO THE MUSCLE/ TENDON. TODAY THE WOUND BED HAD FILLED IN VERY WELL. IMPROVEMENT IN HYPERGRANULAR TISSUE. (B)(6) 2019- LEFT LATERAL LOWER LEG ULCER WITH DRIED SKIN SURROUNDING UPPER PORTION THAT WAS REMOVED TODAY. BASE OF ULCER WITH MAINLY PINK GRANULATION TISSUE. JUST MEDIAL TO THAT ULCER IS A CIRCULAR AREA THAT IS BOGGY- THIS HAS IMPROVED IN SIZE AND APPEARANCE TODAY. THERE IS EXPOSURE OF SUBCUTANEOUS FAT IN THAT BOGGY AREA. NO REDNESS OR ERYTHEMA.
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
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 (B)(6) 2023. SOME COMPLAINTS DATE BACK AS FAR AS 2019, BUT ALL COMPLAINTS WERE REPORTED AT THE SAME TIME IN (B)(6) 2023. WAS THIS DUE TO THE RECALL? ANSWER: "YES. THIS WAS DUE TO THE INTEGRA RECALL." FDA RECALL NUMBER: RES# (B)(4).
THIS REPORT IS TO INCLUDE THE RES# (B)(4).
THIS REPORT IS TO INCLUDE CORRECTION/REMOVAL NUMBER.
THE PRIMATRIX (ID (B)(4) WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE(S) 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.
N/A.
A FACILITY REPORTED: "5/30: L LATERAL LEG WOUND. WOUND BED REMAINS PRIMARILY PINK BUT AGAIN SEEMS TO HAVE A BIT MORE PALE SUBCUTANEOUS TISSUE/ FASCIA PRESENT, THE TENDON APPEARS TO BE A BIT MORE COVERED. DEBRIDEMENT PERFORMED TODAY PRIOR TO PLACEMENT OF PRIMATRIX DERMAL MATRIX GRAFT. SMALL DRAINAGE. PRIMATRIX #1 PLACED: GRAFT. SIZE: 6CMX 6CM. GRAFT LOT#: 1811102. EXPIRATION DATE: 02/28/2023. SALINE LOT#: 8362826. EXPIRATION DATE: 12/31/2021. 6/6: NO SIGN OF INFECTION. WOUND IS APPEARS TO BE MORE COVERED WITH GRANULATION BUDS. PRIMATRIX #2 PLACED GRAFT. SIZE: 6CM X 6CM. GRAFT LOT#:1811102 EXPIRATION DATE: 2023-02-28 SALINE LOT#: 9018542 EXPIRATION DATE: 2022-01-31 6/13: NO SIGNS OF INFECTION. THERE IS REMAINING GRAFT IN THE WOUND. NEGATIVE FOR CHILLS AND FEVER. 6/20: NO SIGNS OF INFECTION. GRAFT INCORPORATED, NO GRAFT AVAILABLE. COLLAGEN GEL PLACED 6/27: NO SIGNS OF INFECTION. PRIMATRIX #3 PLACED. GRAFT SIZE: 6X6 GRAFT LOT#: 1903124 EXPIRATION DATE: 06/30/2023 SALINE LOT#: 9074617 EXPIRATION DATE: 2022: PRIMATRIX GRAFT - LARGE PORTION REMAINS INTACT TODAY. NO SIGNS OF INFECTION. NEGATIVE FOR FEVER AND CHILLS: THERE IS WHAT APPEARS TO BE MOIST LAYER OF GRAFT PRESENT IN SOME LOCATIONS TODAY. NO SIGNS OF INFECTION. CONTINUES TO PROGRESS. NEGATIVE FOR FEVER AND CHILLS: HIS WOUND WAS CLEANED TODAY AND IS SOMEWHAT HYPERGRANULAR, NONE OF HIS GRAFT REMAINS. NO SIGNS OF INFECTION. LOWER LEG/ANKLE INCREASED WITH SWELLING FROM LAST VISIT. SHARP DEBRIDEMENT PERFORMED. NEGATIVE FOR FEVER AND CHILLS: HIS WOUND IS NO LONGER HYPERGRANULAR. NO SIGNS OF INFECTION. NEGATIVE FOR FEVER/CHILLS: HE FEELS THAT HE HAD INCREASED DRAINAGE IN THE BEGINNING OF THE WEEK THAT WAS SEROUS AND IT DECREASED OVER THE LAST 2 DAYS. INITIAL WOUND HAS IMPROVED IN SIZE BUT THE NEW AREA OF ULCERATION IS LARGER AND LOOKS MORE LIKE A BOGGY GRANULOMA. I THINK THE NEW LESION MAY BE ANOTHER SKIN MANIFESTATION OF HIS SCLERODERMA. NEGATIVE FOR FEVER/CHILLS. NO REDNESS OR ERYTHEMA. AREA PROTRUDES 4MM FROM SURROUNDING SKIN: NO HYPERGRANULAR TISSUE; DRAINAGE IS IMPROVED. NEGATIVE FOR FEVER/CHILLS. NO REDNESS OR ERYTHEMA: IT IS PALE PINK WITH FLAT GRANULATION BED - WILL TREAT WITH SHARP DEBRIDEMENT TODAY TO STIMULATE. NEGATIVE FOR FEVER/CHILLS. TACHYCARDIC: SHARP DEBRIDEMENT. NEGATIVE FOR CHILLS/FEVER: THERE IS ONLY A SMALL OPEN ULCER REMAINING. IT IS PALE PINK WITH FLAT GRANULATION BED - GOOD EPITHELIALIZATION FROM THE PERIPHERY. NEGATIVE FOR CHILLS/FEVER. TACHYCARDIC: WOUND IS HEALED. NEGATIVE FOR FEVER/CHILLS. TACHYCARDIC. NO FOLLOW UP WITH WOUND CARE FROM THIS POINT ON. RECALL OF PRIMATRIX 5/2023."
N/A.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1627106 | PRIMATRIX FENESTRATED, 6X6 CM | PRIMATRIX | KGN | TEI BIOSCIENCES INC | 1903124 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |