FDA Adverse Event
Injury
Summary report: N
POLYSORB 0 VL 5X18 BTP-1 DT
MDR report key: 1612746
·
Received February 17, 2010
Report
- Report Number
- 1219930-2010-00103
- Event Type
- Injury
- Date Received
- February 17, 2010
- Date of Event
- January 15, 2010
- Report Date
- January 22, 2010
- Manufacturer
- NORTH HAVEN - USS
- 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). (B) (4).
Description of Event or Problem · 1
PROCEDURE TYPE: UNKNOWN. ACCORDING TO THE REPORTER: WHEN COUNTING THE NUMBER OF NEEDLES AT THE END OF THE PROCEDURE, THE NURSE FOUND THAT 1 NEEDLE WAS MISSING. IT WAS CONFIRMED BY HAVING THE PT X-RAYED THAT NO NEEDLE WAS LEFT IN THE BODY. NO PT HARM. OPERATING TIME WAS EXTENDED MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLYSORB 0 VL 5X18 BTP-1 DT | ABSORBABLE SURGICAL SUTURE | GAM | NORTH HAVEN - USS | A9K0912F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |