FDA Adverse Event
Malfunction
Summary report: N
INSTANT HOT PACK WITH MAGNESIUM SULFATE 5 X 9
MDR report key: 14042075
·
Received April 7, 2022
Report
- Report Number
- 14042075
- Event Type
- Malfunction
- Date Received
- April 7, 2022
- Date of Event
- March 1, 2022
- Report Date
- April 5, 2022
- Manufacturer
- DYNAREX CORPORATION
- Product Code
- IMD
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MA
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
NURSING HAS REPORTED INSTANCES OF HOT PACKS CAUSING 1ST DEGREE BURNS OR ERYTHEMA ON PATIENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2342355 | INSTANT HOT PACK WITH MAGNESIUM SULFATE 5 X 9 | PACK, HOT OR COLD, DISPOSABLE | IMD | DYNAREX CORPORATION | 4516 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |