FDA Adverse Event
Injury
Summary report: N
POLYSORB 0 VL 5X18 BTP-1 DT
MDR report key: 2496370
·
Received March 16, 2012
Report
- Report Number
- 1219930-2012-00267
- Event Type
- Injury
- Date Received
- March 16, 2012
- Date of Event
- February 15, 2012
- Report Date
- February 16, 2012
- 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: DURING THE SUTURE THE DOCTOR FELT THAT THE SWAGE WAS TIGHTER THAN A NORMAL ONE, SO HE TRIED TO PULL IT MORE STRONGLY, THEN THE TIP OF THE NEEDLE BROKE BECAUSE HE HAD GRABBED THE TIP WITH A FORCEPS. USED ANOTHER. NO BLEEDING. NO TISSUE HARM. NO INFORMATION OF OPERATING ROOM TIME EXTENSION. THEY TOOK A X-RAY BUT WEREN'T ABLE TO FIND THE LOST TIP.
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 | B1H0792X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |