FDA Adverse Event
Injury
Summary report: N
8886983161 DXT BI 0 90CM DT-1
MDR report key: 801331
·
Received December 29, 2006
Report
- Report Number
- 9681850-2006-00009
- Event Type
- Injury
- Date Received
- December 29, 2006
- Date of Event
- February 9, 2006
- Report Date
- March 6, 2006
- Manufacturer
- GOSPORT-USS
- Product Code
- GAN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DURING A ROUTINE REVIEW OF OUR COMPLAINTS THIS FTR WAS RE-EVALUATED. BECAUSE THE INFORMATION MADE AVAILABLE IN DESCRIBING THE EVENT DESCRIPTION IS INSUFFICIENT TO SUPPORT A CONCLUSION THAT AN ADVERSE EVENT DID NOT OCCUR, THE COMPLAINT WILL BE REPORTED TO THE FDA AS AN ADVERSE EVENT.
Description of Event or Problem · 1
REPORTEDLY DURING THE PROCEDURE SUTURES BROKE BECAUSE THE TEXTURE OF THE SUTURE WAS ROUGH AND THICK. THE BROKEN SUTURES CAUSED A DELAY IN THE O.R. TIME. NO OTHER INFORMATION WAS MADE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8886983161 DXT BI 0 90CM DT-1 | ABSORBABLE SYNTHETIC SUTURE | GAN | GOSPORT-USS | * | R801408C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |