FDA Adverse Event
Other
Summary report: N
KERLIX ROLL 8 PLY 4.5IN X 3.1 YD STRL
MDR report key: 1416579
·
Received April 1, 2009
Report
- Report Number
- 1018120-2009-00026
- Event Type
- Other
- Date Received
- April 1, 2009
- Report Date
- March 19, 2009
- Manufacturer
- COVIDIEN
- Product Code
- NAB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICAL THERAPIST
Narratives
Additional Manufacturer Narrative · 1
(B) (4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON 3/19/2009 THAT A CUSTOMER HAD AN ISSUE WITH SOME GAUZE. THE CUSTOMER STATED THAT THEY WERE USING THIS GAUZE TO WRAP A HEAL WOUND. THE PATIENT HAD A REACTION, A DERMATITIS OR BLISTERING, ON THE TOP OF THE FOOT. THE CUSTOMER WAS PRESCRIBED KENALOG OINTMENT STEROIDAL CREAM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KERLIX ROLL 8 PLY 4.5IN X 3.1 YD STRL | GAUZE | NAB | COVIDIEN | 6716 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |