FDA Adverse Event
Other
Summary report: N
TELFA NON-ADH DSG 1'S 3X8 STR
MDR report key: 1437092
·
Received August 10, 2009
Report
- Report Number
- 1018120-2009-00034
- Event Type
- Other
- Date Received
- August 10, 2009
- Report Date
- July 24, 2009
- Manufacturer
- COVIDIEN
- Product Code
- FRO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NOT APPLICABLE
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 7/24/2009 THAT A CUSTOMER REPORTED A REACTION TO THE TELFA DRESSING: QUARTER-SIZED REDNESS, SWELLING, ITCHINESS. THE CUSTOMER STATED SHE HAS USED THIS PRODUCT BEFORE WITHOUT A PROBLEM. SHE ALSO STATED TWO CULTURES WERE DONE OF THE AREA AND ONE WAS POSITIVE, REQUIRING KEFLEX, BACTRIBAN. USES ONLY VASELINE WITH THE DRESSING AND STATES SHE IS SENSITIVE TO ADHESIVE TAPE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TELFA NON-ADH DSG 1'S 3X8 STR | NON ADHERENT DRESSING | FRO | COVIDIEN | 1238 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |