FDA Adverse Event
Injury
Summary report: N
ACE BRAND INSTANT COLD COMPRESS
MDR report key: 117878
·
Received September 4, 1997
Report
- Report Number
- 6000017-1997-00003
- Event Type
- Injury
- Date Received
- September 4, 1997
- Date of Event
- October 2, 1996
- Report Date
- August 25, 1997
- Manufacturer
- BECTON DICKINSON CONSUMER PRODUCTS
- Product Code
- IME
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
USER ALLEGEDLY SUFFERED FROM SECOND DEGREE BURNS AFTER APPLYING A COLD COMPRESS ON HIS SHIN SPLITS. THE INJURY CAUSED HIM TO BE ADMITTED TO A HOSPITAL, WHERE HE WAS TREATED FOR HIS WOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACE BRAND INSTANT COLD COMPRESS | COLD COMPRESS | IME | BECTON DICKINSON CONSUMER PRODUCTS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |