FDA Adverse Event
Malfunction
Summary report: N
ACCU-THERM INSTANT HOT COMPRESS
MDR report key: 558197
·
Received October 27, 2004
Report
- Report Number
- MW1033675
- Event Type
- Malfunction
- Date Received
- October 27, 2004
- Date of Event
- October 23, 2004
- Report Date
- October 27, 2004
- Manufacturer
- MEDLINE, INC
- Product Code
- IMD
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
INSTANT HOT PACK SEAM LEAKED SPILLING HOT LIQUID ON RESIDENT'S LEG, CAUSING REDNESS TO THE LEG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-THERM INSTANT HOT COMPRESS | INSTANT HOT COMPRESS | IMD | MEDLINE, INC | * | 04218 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Other |