FDA Adverse Event
Malfunction
Summary report: N
USSC BIOSYN 3/0
MDR report key: 101631
·
Received June 27, 1997
Report
- Report Number
- 1219930-1997-01385
- Event Type
- Malfunction
- Date Received
- June 27, 1997
- Date of Event
- May 30, 1997
- Report Date
- June 3, 1997
- Manufacturer
- UNITED STATES SURGICAL CORP.
- Product Code
- GAN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
12/30/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. THE REPORTED CONDITION HAS BEEN CONFIRMED; HOWEVER, QA IS UNABLE TO RELIABLY DETERMINE THE CAUSE OF THE DIFFICULTY ENCOUNTERED. SEALED UNITS WERE REC'D AND TESTED IN OUR LAB. THE PRODUCT PERFORMED WITHIN SPEC.
Description of Event or Problem · 1
THE DEVICE WAS USED DURING A THYROIDECTOMY PROCEDURE. REPORTEDLY, THE SUTURE BROKE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | USSC BIOSYN 3/0 Implant | MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE | GAN | UNITED STATES SURGICAL CORP. | NA | A7A453H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |