FDA Adverse Event
Injury
Summary report: N
POLYSORB 0 VL 5X18 BTP-1 DT
MDR report key: 3010946
·
Received March 15, 2013
Report
- Report Number
- 1219930-2013-00140
- Event Type
- Injury
- Date Received
- March 15, 2013
- Date of Event
- February 13, 2013
- Report Date
- February 18, 2013
- Manufacturer
- COVIDIEN, FORMERLY US SUR
- Product Code
- GAM
- PMA / PMN Number
- K963253
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: C-SECTION. ACCORDING TO THE REPORTER: DURING PROCEDURE, THE SURGEON NOTICED THE TIP OF NEEDLE WAS MISSING. THEY SEARCHED IN THE CAVITY AND OPERATING ROOM, BUT THE BROKEN TIP WAS NOT FOUND. ALSO, X-RAY WAS TAKEN, BUT THE TIP WAS NOT DETECTED. NEW ONE WAS OPENED TO COMPLETE PROCEDURE. THERE WAS OOZING. THERE WAS NO UNANTICIPATED TISSUE LOSS. PATIENT STATUS IS TO BE REPORTED WITH NO PROBLEM. IT IS UNKNOWN IF THE CASE WAS EXTENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110300 | POLYSORB 0 VL 5X18 BTP-1 DT | ABSORBABLE SUTURE PRODUCT | GAM | COVIDIEN, FORMERLY US SUR | B2H1342X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |