FDA Adverse Event
Injury
Summary report: N
SURGILON 3/0 18 BLACK CV-25 24 DTACH
MDR report key: 2430667
·
Received January 23, 2012
Report
- Report Number
- 9612501-2012-00003
- Event Type
- Injury
- Date Received
- January 23, 2012
- Date of Event
- December 1, 2011
- Report Date
- December 21, 2011
- Manufacturer
- DAVIS AND GECK CARIBE, LTD.
- Product Code
- GAP
- 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: PANCREAS. ACCORDING TO THE REPORTER: DURING SUTURING, THE NEEDLE BROKE. THE TIP OF THE NEEDLE WASN'T RETRIEVED BUT PROBABLY DID NOT FELL INTO THE CAVITY. USED ANOTHER. NO BLEEDING. NO TISSUE DAMAGE. OPERATING ROOM TIME NOT EXTENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGILON 3/0 18 BLACK CV-25 24 DTACH | NONABSORBABLE SUTURE PRODUCT | GAP | DAVIS AND GECK CARIBE, LTD. | D1D0810X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |