MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-13 for MEDICHOICE INSTANT WARM COMPRESS manufactured by Owens & Minor Distribution, Inc..
[138663725]
Inconsistently performing- some too hot while others are too cold. Packaging states up to 115 degrees. Feels much warmer at times than this. Opened box on unit and has no sleeves even though box states "with sleeve. " other boxes have sleeves, signage being placed to use with sleeve or in pillowcase.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8416164 |
| MDR Report Key | 8416164 |
| Date Received | 2019-03-13 |
| Date of Report | 2019-02-04 |
| Date of Event | 2019-02-01 |
| Report Date | 2019-02-04 |
| Date Reported to FDA | 2019-02-04 |
| Date Reported to Mfgr | 2019-03-13 |
| Date Added to Maude | 2019-03-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICHOICE INSTANT WARM COMPRESS |
| Generic Name | PACK, HOT OR COLD, REUSABLE |
| Product Code | IME |
| Date Received | 2019-03-13 |
| Lot Number | 24818-2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OWENS & MINOR DISTRIBUTION, INC. |
| Manufacturer Address | 9120 LOCKWOOD BLVD MECHANICSVILLE VA 23116 US 23116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-13 |