FDA Adverse Event
Injury
Summary report: N
ACE BANDAGE
MDR report key: 1196137
·
Received October 9, 2008
Report
- Report Number
- 2243072-2008-00049
- Event Type
- Injury
- Date Received
- October 9, 2008
- Date of Event
- September 16, 2008
- Report Date
- October 9, 2008
- Manufacturer
- BECTON DICKINSON
- Product Code
- FQM
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: ISSUE: RASH. REGULATORY COMPLIANCE RECEIVED ONE (1) ACE SELF ADHERING BANDAGE (3" WIDTH) IN OPENED PACKAGE (CAT # 207461) WHICH CUSTOMER CLAIMS HAD A RASH ON ANKLE FROM BANDAGE. UPON VISUAL EXAMINATION, BANDAGE APPEARED TO BE HEAVILY USED. ADHESIVE LOSS IN BANDAGE MATERIAL WAS ALSO OBSERVED. CANNOT CONFIRM COMPLAINT AS MFG DEFECT. UNABLE TO RUN COMPLAINT HISTORY CHECK OR DEVICE HISTORY REVIEW AS LOT NUMBER IS UNKNOWN. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.
Description of Event or Problem · 1
CUSTOMER REPORTED, HIS WIFE USED ACE SELF ADHERING BANDAGE ON HER ANKLE AND SHE GOT A RASH. CONSUMER DID SEEK MEDICAL ATTENTION AND DOCTOR PRESCRIBED COLTRIMACOLE CREAM AS TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACE BANDAGE | 3 " SELF ADHERING BANDAGE | FQM | BECTON DICKINSON | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |