FDA Adverse Event
Injury
Summary report: N
POLYSORB 1 UD 5 X 18 BTP-1 DT
MDR report key: 2644794
·
Received June 29, 2012
Report
- Report Number
- 1219930-2012-00551
- Event Type
- Injury
- Date Received
- June 29, 2012
- Date of Event
- May 31, 2012
- Report Date
- June 1, 2012
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL
- Product Code
- GAM
- PMA / PMN Number
- K963253
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: C-SECTION. ACCORDING TO THE REPORTER: WHILE USING ON PT, TIP OF NEEDLE WAS BROKEN. THE BROKEN PIECE FELL INTO CAVITY AND WAS RETRIEVED AFTER MORE THAN 2-HOURS SEARCH. USING NEW ONE, PROCEDURE WAS COMPLETED. NO BLEEDING. NO TISSUE DAMAGE. NO PT HARM. OPERATING ROOM TIME WAS EXTENDED BY MORE THAN 30 MINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLYSORB 1 UD 5 X 18 BTP-1 DT | ABSORBABLE SUTURING PRODUCT | GAM | COVIDIEN, FORMERLY US SURGICAL | B1E0910X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |