FDA Adverse Event
Malfunction
Summary report: N
COATED VICRYL (POLYGLACTIN 910) SUTURE
MDR report key: 1850242
·
Received September 22, 2010
Report
- Report Number
- 2210968-2010-01149
- Event Type
- Malfunction
- Date Received
- September 22, 2010
- Date of Event
- July 28, 2010
- Report Date
- August 23, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- GAM
- PMA / PMN Number
- K022269
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE FOR TRAUMA (MOTORCYCLE ACCIDENT) ON (B)(6) 2010 AND SUTURE WAS USED. THE NEEDLE BROKE IN THE LIVER WHILE PULLING OUT THE SUTURE. DUE TO THE POTENTIAL INCREASED TRAUMA TO THE LIVER REQUIRED TO FIND AND REMOVE THE NEEDLE, A DECISION WAS MADE TO LEAVE THE NEEDLE FRAGMENT BEHIND AND REMOVE IT AT A LATER DATE. APPROXIMATELY 1/3 OF SWAGE END OF THE NEEDLE WAS REMOVED AND 2/3 REMAINED IN PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COATED VICRYL (POLYGLACTIN 910) SUTURE | SUTURE, ABSORBABLE | GAM | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR |