MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-05 for NOVAPLUS INSTANT HOT PACK manufactured by Cardinal Health 200, Llc.
[119640358]
Cardinal novaplus instant hot pack busted when activated and the contents of the package exploded out into a staff member's neck and chest. A staff member reported attempting to activate the cardinal novaplus instant hot pack and the contents burst out of the packaging onto her neck / chest and the top of her uniform was down to her abdomen. She complained of a burning sensation to her exposed skin. She reported the incident to the administrative mgr who sent her down to our facility's emergency room. The emergency room evaluated the staff member and sent her home to take a shower.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079635 |
| MDR Report Key | 7851080 |
| Date Received | 2018-09-05 |
| Date of Report | 2018-08-21 |
| Date of Event | 2018-08-21 |
| Date Added to Maude | 2018-09-06 |
| 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 | 0 |
| Brand Name | NOVAPLUS INSTANT HOT PACK |
| Generic Name | PACK, HOT OR COLD, REUSABLE |
| Product Code | IME |
| Date Received | 2018-09-05 |
| Lot Number | 27-3961 |
| Device Availability | Y |
| 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 | 1. Required No Informationntervention | 2018-09-05 |