MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-15 for INFANT HEEL WARMER manufactured by Cardinal Health 200, Llc..
[133519033]
Heel warmer placed on infant's foot. Package broke/exploded onto infant's foot, bedding and crib.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083140 |
| MDR Report Key | 8253099 |
| Date Received | 2019-01-15 |
| Date of Report | 2019-01-14 |
| Date of Event | 2019-01-11 |
| Date Added to Maude | 2019-01-16 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | INFANT HEEL WARMER |
| Generic Name | INFANT HEEL WARMER (CHEMICAL HEAT PACK) |
| Product Code | MPO |
| Date Received | 2019-01-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC. |
| Manufacturer Address | WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-15 |