FDA Adverse Event
Injury
Summary report: N
BIOSYN 0 VL 60 BTP-X LOOP
MDR report key: 1379370
·
Received May 8, 2009
Report
- Report Number
- 1219930-2009-00326
- Event Type
- Injury
- Date Received
- May 8, 2009
- Date of Event
- April 3, 2009
- Report Date
- April 20, 2009
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GAN
- PMA / PMN Number
- K000037
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS BEEN RECEIVED BY THE QA DEPARTMENT IN 2009, BUT NOT YET INVESTIGATED.
Description of Event or Problem · 1
PROCEDURE TYPE: GASTRECTOMY. ACCORDING TO THE REPORTER: PRODUCT WAS USED FOR ABDOMINAL CLOSURE. TEN DAYS AFTER SURGERY, THE PATIENT COUGHED AND THE SUTURE BROKE AND THE ABDOMINAL WALL OPENED. IT WAS SOON FIXED WITH A DIFFERENT PRODUCT. THERE WAS NO ADDITIONAL BLEEDING AND NO TISSUE DAMAGE. NOTHING FELL INTO PATIENT CAVITY AND PATIENT STATUS IS OK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOSYN 0 VL 60 BTP-X LOOP | ABSORBABLE SUTURE PRODUCT | GAN | NORTH HAVEN - USS | A8K381 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |