MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-13 for INFANT HEEL WARMER manufactured by Philips Medical Systems.
[127228797]
Rn and staff at bedside were opening up philips infant heel warmers to place on pt. Staff member across from rn opened up heel warmer and contents were expelled on rn's arm and face. Rn immediately washed off contents and later noticed burning sensation on arm. Superficial burn had developed on rn's arm from heel warmer contents. Rn evaluated in emergency room (er. )
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081209 |
| MDR Report Key | 8069507 |
| Date Received | 2018-11-13 |
| Date of Report | 2018-11-07 |
| Date of Event | 2018-10-26 |
| Date Added to Maude | 2018-11-14 |
| 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 | INFANT HEEL WARMER |
| Generic Name | INFANT HEEL WARMER |
| Product Code | MPO |
| Date Received | 2018-11-13 |
| Lot Number | 100294 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-13 |