MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for NOVAPLUS INSTANT HOT PACK V11443-012B manufactured by Cardinal Health 200, Llc.
[181765259]
Hot pack exploded upon activation. No pt or staff harm. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093341 |
| MDR Report Key | 9763960 |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-20 |
| Date Added to Maude | 2020-02-27 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVAPLUS INSTANT HOT PACK |
| Generic Name | PACK, HOT OR COLD, DISPOSABLE |
| Product Code | IMD |
| Date Received | 2020-02-26 |
| Catalog Number | V11443-012B |
| Lot Number | V0A004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-26 |