MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-07 for MEDICHOICE INSTANT WARM COMPRESS manufactured by Owens & Minor Distribution, Inc.
[144276543]
Potential risk to patients using medichoice instant warm compress. The compress, even when used as directed (i. E. -in the protective sleeve provided by the manufacturer), may cause redness and discomfort when applied to affected areas.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8586078 |
| MDR Report Key | 8586078 |
| Date Received | 2019-05-07 |
| Date of Report | 2019-02-21 |
| Date of Event | 2019-02-20 |
| Report Date | 2019-04-19 |
| Date Reported to FDA | 2019-04-19 |
| Date Reported to Mfgr | 2019-05-07 |
| Date Added to Maude | 2019-05-07 |
| 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, REUSEABLE |
| Product Code | IME |
| Date Received | 2019-05-07 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OWENS & MINOR DISTRIBUTION, INC |
| Manufacturer Address | 9120 LOCKWOOD BOULEVARD MECHANICSVILLE VA 23116 US 23116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-07 |