FDA Adverse Event
Other
Summary report: N
XPRT 8X8 AMD FOAM DRSG
MDR report key: 3817529
·
Received May 8, 2014
Report
- Report Number
- 1018120-2014-00008
- Event Type
- Other
- Date Received
- May 8, 2014
- Report Date
- April 14, 2014
- Manufacturer
- COVIDIEN
- Product Code
- FRO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2014. AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A FOAM DRESSING. THE CUSTOMER REPORTS THE LEG BECAME VERY RED AND INFLAMED. THE CUSTOMER REPORTS LOPROX CREAM 1% WAS PRESCRIBED BY A PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279576 | XPRT 8X8 AMD FOAM DRSG | FOAM DRESSING | FRO | COVIDIEN | 55588AMDX | 130002426862 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |