FDA Adverse Event
Injury
Summary report: N
SUGRIPRO 4/0 18 BLUE C-13 05G
MDR report key: 3131053
·
Received May 21, 2013
Report
- Report Number
- 2647580-2013-00284
- Event Type
- Injury
- Date Received
- May 21, 2013
- Report Date
- April 23, 2013
- Manufacturer
- COVIDIEN, FORMERLY USSC
- Product Code
- GAW
- PMA / PMN Number
- K954808
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE CUSTOMER REPORT: COMPLETED SURGERY AND SKIN SUTURED NEEDLE FOLLOWS THE THREAD: BEGINNING WOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 226179 | SUGRIPRO 4/0 18 BLUE C-13 05G | SURGIPRO | GAW | COVIDIEN, FORMERLY USSC | T0J0088MV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other |