FDA Adverse Event
Injury
Summary report: N
VLOC 180 ABS 0 GR 24 GS-21
MDR report key: 3940718
·
Received July 2, 2014
Report
- Report Number
- 1219930-2014-00503
- Event Type
- Injury
- Date Received
- July 2, 2014
- Date of Event
- June 4, 2014
- Report Date
- June 24, 2014
- Manufacturer
- COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
- Product Code
- GAM
- PMA / PMN Number
- K091087
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: GYNECOLOGY. ACCORDING TO THE REPORTER: EVENT WAS NOTIFIED TO (B)(6) AS AN INCIDENT. THE INTERVENTION WAS PERFORMED ON (B)(6), AND THE DEVICE WAS USED TO SUTURE VAGINAL CUPULA. AFTER SEVERAL DAYS (B)(6) THEY REALIZED THAT THE SUTURE THREAD WAS BROKEN, ALTHOUGH THEY CAN NOT SAY WHEN IT BROKE. THIS RESULTED WITH THE PATIENT NEEDING TO BE HOSPITALIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 385303 | VLOC 180 ABS 0 GR 24 GS-21 | VLOC SUTURE | GAM | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES | A2F0823X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |