FDA Adverse Event
Injury
Summary report: N
POLYSORB 0 VL 5X18 BTP-1 DT
MDR report key: 2120286
·
Received June 1, 2011
Report
- Report Number
- 1219930-2011-00463
- Event Type
- Injury
- Date Received
- June 1, 2011
- Date of Event
- May 12, 2011
- Report Date
- May 16, 2011
- Manufacturer
- UNITED STATES SURGICAL
- 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 TIP OF THE NEEDLE BROKE WHILE IN USE ON PATIENT. THE BROKEN NEEDLE WAS RETRIEVED FROM CAVITY. HOWEVER, ANOTHER NEEDLE ALSO BROKE AND DOCTOR DID NOT NOTICE IT UNTIL THEY FINISHED CLOSING ABDOMEN. SINCE THE BROKEN TIP COULD NOT BE FOUND OUTSIDE THE PATIENT'S BODY, THEY HAD TO RE-OPEN THE ABDOMEN. IT WAS NOT REPORTED IF THE BROKEN TIP WAS FOUND. OPERATING TIME HAD TO BE EXTENDED. NO BLEEDING WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLYSORB 0 VL 5X18 BTP-1 DT | ABSORBABLE SUTURE PRODUCT | GAM | UNITED STATES SURGICAL | A0M0131F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |