MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-20 for CARDINAL HEALTH 11460-010T manufactured by Cardinal Health 200, Llc.
[145498710]
Registered nurse (rn) attempted to pop infant heel warmer to place on patient's hand prior to iv insertion. Infant heel warmer broke open, contents landed on rn's hands and patient's mother's clothing. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8623203 |
| MDR Report Key | 8623203 |
| Date Received | 2019-05-20 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-05-06 |
| Report Date | 2019-05-07 |
| Date Reported to FDA | 2019-05-07 |
| Date Reported to Mfgr | 2019-05-20 |
| Date Added to Maude | 2019-05-20 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | CARDINAL HEALTH |
| Generic Name | INFANT HEEL WARMER (CHEMICAL HEAT PACK) |
| Product Code | MPO |
| Date Received | 2019-05-20 |
| Model Number | 11460-010T |
| Catalog Number | 11460-010T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 808 W HIGHWAY 24 MOBERLY MO 65270 US 65270 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-20 |