SURGIMEND E3.0 10CM X 25CM FEN
Report
- Report Number
- 3004170064-2023-00020
- Event Type
- Injury
- Date Received
- July 27, 2023
- Report Date
- June 17, 2024
- Manufacturer
- TEI BIOSCIENCES INC
- Product Code
- FTM
- PMA / PMN Number
- K083898
- Removal / Correction Number
- 3004170064-05/23/2023-00
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 117
Narratives
DHR - NO ANOMALIES IN THE MANUFACTURING PROCESS/DHR THAT COULD BE CORRELATED TO THE CAUSE OF THIS COMPLAINT.
THIS REPORT IS TO PROVIDE THE RES# (B)(4).
SURGIMEND WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. A ROOT CAUSE OF ¿DATA INTEGRITY ISSUES¿ FOR ENDOTOXIN TESTING CANNOT BE RULED OUT. 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. A VOLUNTARY RECALL WAS INITIATED FOR ALL PRODUCTS MADE IN THE MANUFACTURING SITE DUE TO POTENTIALLY HIGH LEVELS OF ENDOTOXIN IN THE PRODUCTS. A CORRECTIVE AND PREVENTATIVE ACTION HAS BEEN OPENED TO ADDRESS DATA INTEGRITY ISSUES IDENTIFIED WITH IN-PROCESS AND FINISHED GOODS ENDOTOXIN TESTING.
SUPPLEMENTAL/FOLLOW-UP REPORT TO ADD "CORRECTION/REMOVAL RPT NUMBER" (H9).
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: "THE PATIENT WAS SUBMITTED TO 2 SURGERIES WITH APPLICATION OF 1 MATRIX ON EACH SURGERY, BUT THE SURGEON NEVER RELATED THE USE OF SURGIMEND, WHICH SHE HAD BEEN USING FOR AROUND 5 YEARS, WITH THE DRASTIC COMPLICATIONS THAT OCCURRED AND WHICH REQUIRED A HOSPITAL STAY OF MORE THAN 3 MONTHS." 1 ST SURGERY: 606-304-002. LOT 2008032. EXPIRED DATE : 2025-07-31. 2ND SURGERY: 606-300-008. LOT: 2006019. EXPIRED DATE: 2025-04-30. ADDITIONAL INFORMATION RECEIVED: PATIENT'S AGE, GENDER AND WEIGHT ? "MALE, 34 YEARS, 80KG". REASON FOR SURGIMEND USE AND LOCATION? "CORRECTION OF THIGH MUSCLE HERNIA". DID THE PATIENT HAVE A FEVER? IF YES, PROVIDE DATE, DURATION, TREATMENT, AND TEMPERATURE NUMBER? "HAD FEVER FROM THE SECOND TO THE FIFTH DAY AFTER SURGERY. DONT KNOW THE NUMBER. WAS DOING PARACETAMOL, CLONIXIN AND TRAMADOL. HAD AGGRAVATION OF PAIN ON THE SECOND DAY AND CUTANEOUS INFLAMMATION SIGNS AND SEROMA ON THE THIRD DAY AFTER SURGERY, STARTED CIPROFLOXACIN BUT THE INFLAMMATION SIGNS GOT WORSE AND VERY EXTENSIVE. GOT LOW URINARY OUTPUT AND GENERAL BAD APPEARANCE. NEEDED HOSPITAL READMISSION ON THE FOURTH DAY." WHAT WAS THE TREATMENT FOR THE SECOND CASE (INFLAMMATORY REACTION WITH RED SKIN AND SEROMA) AND IF IT REQUIRED ANY MEDICAL INTERVENTION? "THE SEROMA WAS MEDICAL UNTREATABLE AND THREE MONTHS LATER HAD TO PERFORM SURGERY - REMOVED THE PREVIOUS MEMBRANE AND APPLIED OTHER MEMBRANE. ON THE SECOND DAY HAD CUTANEOUS INFLAMMATION SIGNS (THAT LAST FOR 3 WEEKS, NOT SO EXTENSIVE AS ON THE PREVIOUS SURGERY) AND PAIN. GOT SEROMA MEDICALLY SOLVED."
N/A.
N/A.
N/A.
1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3004170064-2023-00021. A FACILITY REPORTED A PATIENT HAD A SURGIMEND APPLIED (ID 606-304-002) IN (B)(6)2022. AFTER 48 HOURS THE PATIENT PRESENTED WITH INFLAMMATION AND AN INFECTION THAT THE SURGEON TRIED TO CONTROL DURING A TIME . ON AN UNKNOWN DATE, THE PATIENT RETURNED TO OPERATIVE ROOM FOR PRODUCT REMOVAL AND DEBRIDEMENT. AFTER EVERYTHING CLEAN AND THE INFECTION WAS CONTROLLED, SURGEON APPLIED ANOTHER SURGIMEND (ID 606-304-002) IN (B)(6) 2022 . AFTER 24 HOURS THE PATIENT PRESENTED WITH SYMPTOMS OF INFLAMMATORY REACTION WITH RED SKIN IN THE AREA AND AFTER THAT SHE HAD A SEROMA THAT WAS SOLVED BY THE BEGINNING OF (B)(6)2022.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 637914 | SURGIMEND E3.0 10CM X 25CM FEN | SURGIMEND | FTM | TEI BIOSCIENCES INC | 2008032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Male |