FDA Adverse Event
Other
Summary report: N
VISTEC SPG 4X4 NON ST 10S 16 PLY
MDR report key: 2872373
·
Received December 6, 2012
Report
- Report Number
- 1018120-2012-00024
- Event Type
- Other
- Date Received
- December 6, 2012
- Report Date
- November 12, 2012
- Manufacturer
- COVIDIEN
- Product Code
- GDY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. PRODUCT MONITORING CONTACTED THE CUSTOMER REQUESTING ADDITIONAL INFORMATION BUT NO FURTHER INFORMATION WAS AVAILABLE. IF ADDITIONAL INFORMATION IS OBTAINED, THE MEDWATCH FORM WILL BE UPDATED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A XRAY DETECTABLE SPONGE. THE CUSTOMER REPORTS THAT DURING A SURGICAL PROCEDURE ON AN OPEN WOUND, THE SPONGE FELL APART IN THE WOUND. THE CUSTOMER FURTHER REPORTS, THAT THE FRAYED SPONGE PARTICLES WERE REMOVED IMMEDIATELY WITH NO ILL EFFECT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISTEC SPG 4X4 NON ST 10S 16 PLY | XRAY DETECTABLE SPONGE | GDY | COVIDIEN | 7148 | 1647162X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |