FDA Adverse Event
Other
Summary report: N
COATED VICRYL (POLYGLACTIN 910) SUTURE
MDR report key: 719956
·
Received May 26, 2006
Report
- Report Number
- 2210968-2006-00394
- Event Type
- Other
- Date Received
- May 26, 2006
- Date of Event
- April 27, 2006
- Report Date
- April 27, 2006
- Manufacturer
- ETHICON, INC.
- Product Code
- GAM
- PMA / PMN Number
- k946271
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
H-6: NO CONCLUSION CAN BE DRAWN AT THIS TIME. 510(K)# IS K946271
Description of Event or Problem · 1
A NEEDLE PREMATURELY RELEASED FROM THE SUTURE. THE SURGEON LOST BOTH VISUAL AND TACTILE CONTROL OF THE NEEDLE SUBSEQUENT TO THE EVENT THAT RESULTED IN A RETAINED FOREIGN BODY. THE SURGEON REPORTS NO ADVERSE PT CONSEQUENCE AND OPINES NO ANTICIPATED ADVERSE CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COATED VICRYL (POLYGLACTIN 910) SUTURE | SUTURE, ABSORBABLE | GAM | ETHICON, INC. | NA | UPM632 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |