MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-20 for NOVAPLUS INSTANT HOT PACK V11443-012B manufactured by Cardinal Health.
[180852738]
Add'l info received from reporter on 02/20/2020. "hot pack ruptured when staff member attempted to activate by squeezing. The content caused redness and mild irritation to staff member's arm. A second hot pack ruptured during the same shift involving a different staff member. No harm to pt. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093179 |
| MDR Report Key | 9739732 |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-02-05 |
| Date Added to Maude | 2020-02-21 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 2020-02-20 |
| Catalog Number | V11443-012B |
| Lot Number | V9S079 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | DUBLIN OH 43017 US 43017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-20 |