FDA Adverse Event
Injury
Summary report: N
BAND AID
MDR report key: 3523037
·
Received December 12, 2013
Report
- Report Number
- MW5033432
- Event Type
- Injury
- Date Received
- December 12, 2013
- Date of Event
- December 9, 2013
- Report Date
- December 11, 2013
- Manufacturer
- J & J
- Product Code
- FQM
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
(B)(4) BANDAIDS AND GENERIC BRANDS ((B)(4) AND OTHERS) FLEXIBLE CLOTH BANDAIDS - STICK TOO MUCH, IMPOSSIBLE TO REMOVE WITHOUT EXCESSIVE PAIN, RIPPING OF SKIN. CREATED RASH THAT STAYS FOR DAYS. EVERYONE I KNOW IS COMPLAINING ABOUT OTC BANDAIDS THAT ARE TOO HARD TO REMOVE. HAS THE INDUSTRY STARTED USING A NEW TYPE OF ADHESIVE OR REFORMULATED IT. EVEN THE KIND FOR SENSITIVE SKIN IS DIFFICULT TO REMOVE WITHOUT PAIN, TEARING AND RASH. MY HUSBAND HAS A SCAR ON HIS ELBOW FROM RIPPED SKIN. SOAKING IN WATER, OIL, NOTHING SEEMS TO WORK TO SOFTEN THE ADHESIVE. DATES OF USE: ONE WEEK, CHANGED DAILY. DIAGNOSIS OR REASON FOR USE: COVER SURGICAL INCISION, CHANGE DAILY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 650418 | BAND AID | FLEXIBLE CLOTH | FQM | J & J | |||
| 650419 | GENERIC BAND AIDS | BAND AIDS | FQM | RITE AID | |||
| 650420 | BAND AIDS | BAND AIDS | FQM | CURAD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |