FDA Adverse Event
Injury
Summary report: N
UNKNOWN SUTURE PRODUCT
MDR report key: 2143299
·
Received June 29, 2011
Report
- Report Number
- 2210968-2011-00836
- Event Type
- Injury
- Date Received
- June 29, 2011
- Date of Event
- April 5, 2011
- Report Date
- June 1, 2011
- Manufacturer
- ETHICON, INC
- Product Code
- GAO
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PDS LL PLUS ANTIBACTERIAL SUTURE. PDS II (POLYDIOXANONE) SUTURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A MIDLINE LAPAROTOMY ON (B)(6) 2011 AND SUTURE WAS USED FOR CONTINUOUS ABDOMINAL FASCIAL CLOSURE. THE PATIENT DEVELOPED WOUND HEALING DISORDER AFTER INFECTED HEMATOMA WITH INTACT FASCIA. ON (B)(6) 2011, THE PATIENT UNDERWENT WOUND DEBRIDEMENT AND VAC - SPONGE THERAPY. AT POSTOPERATIVE VISIT NUMBER FOUR, A CHANGE OF DRESSING TO ALGINAT/BIATIN WAS POSSIBLE. CURRENTLY, THE PATIENT IS STABLE AND THE WOUND IS CLEAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN SUTURE PRODUCT | SUTURE | GAO | ETHICON, INC | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |