MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-16 for MEDICHOICE 69904 1480069904 manufactured by Owens & Minor Distribution, Inc..
[5266091]
While the patient was waiting in the emergency room, the compress she had been given burst and leaked. Patient informed nursing staff that she had been burned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4377235 |
| MDR Report Key | 4377235 |
| Date Received | 2014-12-16 |
| Date of Report | 2014-12-16 |
| Date of Event | 2014-12-05 |
| Report Date | 2014-12-16 |
| Date Reported to FDA | 2014-12-16 |
| Date Reported to Mfgr | 2015-01-02 |
| Date Added to Maude | 2015-01-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICHOICE |
| Generic Name | INSTANT COLD PACK |
| Product Code | MUI |
| Date Received | 2014-12-16 |
| Model Number | 69904 |
| Catalog Number | 1480069904 |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OWENS & MINOR DISTRIBUTION, INC. |
| Manufacturer Address | 9120 LOCKWOOD BLVD MECHANICSVILLE ME * US * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-16 |