FDA Adverse Event
Injury
Summary report: N
POLYSORB 2-0 VL 5 X 18 BTP-1 DT
MDR report key: 2978456
·
Received February 22, 2013
Report
- Report Number
- 1219930-2013-00092
- Event Type
- Injury
- Date Received
- February 22, 2013
- Date of Event
- January 16, 2013
- Report Date
- January 23, 2013
- Manufacturer
- COVIDIEN, FORMELRY US
- 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: THE SURGEON HELD THE NEEDLE AT THE TIP AND IT BROKE WHILE SUTURING THE FASCIA. THE BROKEN TIP DROPPED IN THE CAVITY. THE SURGEON SEARCHED IT FOR ABOUT 20 MINUTES, BUT COULD NOT FIND. CT SCAN WAS ALSO UNABLE TO DETECT IT. USED ANOTHER, BUT THE NEEDLE WAS BENT WHILE SUTURING. USED ANOTHER TO COMPLETE PROCEDURE. THERE WAS OOZING. THERE WAS NO UNANTICIPATED TISSUE LOSS. THE PATIENT IS UNDER OBSERVATION. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78945 | POLYSORB 2-0 VL 5 X 18 BTP-1 DT | POLYSORB | GAM | COVIDIEN, FORMELRY US |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |