FDA Adverse Event
Malfunction
Summary report: N
CURITY LAP SPG 18X18 P-W STR TR 5'S
MDR report key: 1930568
·
Received December 1, 2010
Report
- Report Number
- 1018120-2010-00024
- Event Type
- Malfunction
- Date Received
- December 1, 2010
- Date of Event
- November 16, 2010
- Report Date
- November 17, 2010
- Manufacturer
- COVIDIEN
- Product Code
- GDY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2010. AN INVESTIGATION IS UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A CURITY LAP SPONGE. THE CUSTOMER REPORTED THE PRODUCT LEFT LONG FIBERS IN THE ABDOMINAL CAVITY OF THE PATIENT. THE SURGEON WAS ABLE TO REMOVE ALL OF THE FIBERS DURING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURITY LAP SPG 18X18 P-W STR TR 5'S | LAP SPONGE | GDY | COVIDIEN | 6022 | 02022701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |