FDA Adverse Event
Injury
Summary report: N
PDS II (POLYDIOXANONE) SUTURE
MDR report key: 294471
·
Received September 6, 2000
Report
- Report Number
- 2210968-2000-00329
- Event Type
- Injury
- Date Received
- September 6, 2000
- Date of Event
- July 12, 2000
- Report Date
- August 4, 2000
- Manufacturer
- ETHICON, INC. SAN ANGELO
- Product Code
- GAN
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PHYSICIAN REPORTED THAT SUTURE LINE BROKE AT THE RIGHT SIDE OF THE INCISION AND UNRAVELED FOLLOWING GYNECOLOGIC PROCEDURE. PT WAS REPORTEDLY VOMITING AT THE TIME THE SUTRUE WAS NOTED TO BREAK. PT WAS RETURNED TO THE OPERATING ROOM FOR REPAIR. PT RECOVERED AND NO FURTHER COMPLICATIONS WERE NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PDS II (POLYDIOXANONE) SUTURE | SUTURE, ABSORABLE | GAN | ETHICON, INC. SAN ANGELO | NA | MB2429 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR |