MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for NOVAPLUS INSTANT HOT PACK V11443-012B manufactured by Cardinal Health 200, Llc.
[185506183]
Rn was popping hot pack for patient. It popped easily but then ruptured and got on the patient's face, hair, gown, bed and floor, and on the rn's hands and scrubs. Pt cleaned up, bed changed & floor wiped up. No burning sensation or injury noted or reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9897218 |
| MDR Report Key | 9897218 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-24 |
| Report Date | 2020-03-24 |
| Date Reported to FDA | 2020-03-24 |
| Date Reported to Mfgr | 2020-03-30 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 2020-03-30 |
| Model Number | V11443-012B |
| Catalog Number | V11443-012B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 3651 BIRCHWOOD DRIVE WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |