FDA Adverse Event Other Summary report: N

PRIMATRIX 18MM

MDR report key: 18255662 · Received December 1, 2023

Report

Report Number
MW5148663
Event Type
Other
Date Received
December 1, 2023
Date of Event
January 12, 2021
Report Date
November 30, 2023
Manufacturer
INTEGRA LIFESCIENCES CORPORATION
Product Code
KGN
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
AR, US
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

ON (B)(6) 2020-PT PRESENTS FOR INITIAL WOUND CARE VISIT REGARDING AN ULCER ON HER RIGHT FOOT. IT HAS BEEN PRESENT FOR APPROX 6 WEEKS- SHE DOES NOT KNOW THE CAUSE OF THE SORE. ON (B)(6) 2020- PATIENT NON-COMPLIANT WITH NOT BEARING WEIGHT. FAMILY IS "MILKING" ULCER. PRIMATRIX GRAFT #1 PLACED. GRAFT LOT#: 1912024 ON (B)(6) 2020- PT HERE FOR FOLLOW UP OF RIGHT MEDIAL / PLANTAR FOOT ULCER HER ORIGINAL WOUND MEASURES FAIRLY STABLE TO MARGINALLY INCREASED TODAY- THE SMALL OPENING MORE PROXIMAL ON THE MEDIAL HEEL HAS RESOLVED. GRAFT #2 PLACED. GRAFT LOT#: 2003022 NO NEW INFLAMMATORY/INFECTION SIGNS DOCUMENTED. ON (B)(6) 2020- WILL USE COLLAGEN THIS WEEK BECAUSE NO GRAFT AVAILABLE. DRAINAGE IS IMPROVED. OPENING MORE POSTERIORLY - MEDIAL HEEL- NO DRAINAGE TODAY- RESOLVED. ON (B)(6) 2020- PT HERE FOR FOLLOW UP OF RIGHT MEDIAL / PLANTAR FOOT ULCER. HER ORIGINAL WOUND MEASURES IMPROVED TODAY. THE SMALL OPENING MORE PROXIMAL ON THE MEDIAL HEEL HAS RESOLVED. SHE HAS BEEN APPROVED FOR PRIMATRIX GRAFT - SHE HAS HAD 2 PRIOR GRAFTS. GRAFT IS AVAIL TODAY SO WE WILL PLACE. WILL PLACE PRIMATRIX # 3 TODAY GRAFT LOT#: 2003022 ON (B)(6) 2020- IT SEEMS TO BE CLOSING IN. DRAINAGE IS IMPROVED. NO GRAFT IS AVAILABLE TODAY SO WE WILL USE COLLAGEN. ON (B)(6) 2021- HER ORIGINAL WOUND MEASURES IMPROVED TODAY. HAS SOME PERIWOUND IRRITATION AND PEELING SKIN MORE PROXIMALLY ON THE ANKLE - WILL USE TRIAMCINOLONE/ ZINC PASTE AT THIS SITE - I HAVE ASKED HER NOT TO SCRATCH OR PICK AT THIS AREA. ON (B)(6) 2021-PT HERE FOR FOLLOW UP OF RIGHT MEDIAL / PLANTAR FOOT ULCER. HER ORIGINAL WOUND MEASURES SL LARGER TODAY. NO GRAFT WAS AVAILABLE LAST WEEK SO WE USED BIOSTEP COLLAGEN = SHE THINKS THIS HAS WORKED AS WELL AS ANYTHING - SO WE WILL CONTINUE FOR NOW. SHE HAS SOME PERIWOUND IRRITATION AND PEELING SKIN MORE PROXIMALLY ON THE ANKLE - WILL USE TRIAMCINOLONE/ ZINC PASTE AT THIS SITE - I HAVE ASKED HER NOT TO SCRATCH OR PICK AT THIS AREA. ON (B)(6) 2021- PT HERE FOR FOLLOW UP OF RIGHT MEDIAL / PLANTAR FOOT ULCER. HER ORIGINAL WOUND MEASURES SL LARGER TODAY. - THE SMALL OPENING MORE PROXIMAL ON THE MEDIAL HEEL HAS RESOLVED. SHE HAS TRANSITIONED TO REGULAR SHOES AND TODAY IS WEARING CROCS - WE DISCUSSED CONSIDERATION OF CUSTOM DIABETIC SHOES WHICH IN THE PAST SHE HAS BEEN OPPOSED TO , HOWEVER RECENTLY SHE AGREED - UNFORTUNATELY SHE IS STILL WEARING THE CROCS AND I CAN SEE AN AREA WHERE SHE SEEMS TO BE GETTING SOME FRICTION- I HAVE ASKED HER AGAIN TO TRY TO AVOID PRESSURE AND FRICTION TO THIS SITE = ADVISED SOFT SOLED SHOES WITH GOOD CUSHION AND STRETCH UNTIL SHE GETS HER CUSTOM DIABETIC SHOES. RECENTLY NO GRAFT HAS BEEN AVAILABLE SO WE HAVE BEEN USING BIOSTEP COLLAGEN = LAST WEEK CHANGED TO MEDIHONEY = I WANT TO TRY STIMULEN COLLAGEN POWDER THIS WEEK-WE WILL ORDER FOR HER. SHE HAS SOME PERIWOUND IRRITATION AND PEELING SKIN MORE PROXIMALLY ON THE ANKLE - - I HAVE ASKED HER NOT TO SCRATCH OR PICK AT THIS AREA. SHE HAS AQUAPHOR SHE WILL USE TO THIS SITE. ON (B)(6) 2021- WOUND MEASURES SL IMPROVED TODAY RECALL OF PRIMATRIX ON 05/2023. REFERENCE REPORTS: #MW5148662, #MW5148664.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2205074 PRIMATRIX 18MM WOUND DRESSING WITH ANIMAL-DERIVED MATERIAL(S) KGN INTEGRA LIFESCIENCES CORPORATION 1912024

Patients

Seq Age Sex Outcome Treatment
1 63 YR Female Other COLLAGEN GEL.