MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-09-20 for ARGYLE MH00002T manufactured by Covidien.
[120854683]
Submit date: 9/20/18 the complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. If additional information or the sample is received, the investigation will be reopened and responded to accordingly. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[120854684]
The customer reports the product broke on baby's skin while trying to activate the heel warmer by punching it. The heel warmer exploded on nurse, the baby, and another nurse. The solution crystallized on the baby. The baby was then washed multiple times and the crystals kept reforming. Additional information from the customer states the crystals have since went away from the patients skin and there was no harm/injury to the patient of staff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219103-2018-00020 |
| MDR Report Key | 7893432 |
| Report Source | OTHER |
| Date Received | 2018-09-20 |
| Date of Report | 2018-11-08 |
| Date of Event | 2018-08-17 |
| Date Mfgr Received | 2018-09-05 |
| Date Added to Maude | 2018-09-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 2 LUDLOW PARK DR |
| Manufacturer City | CHICOPEE MA 010221318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 010221318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARGYLE |
| Generic Name | INFANT HEEL WARMER (CHEMICAL HEAT PACK) |
| Product Code | MPO |
| Date Received | 2018-09-20 |
| Model Number | MH00002T |
| Catalog Number | MH00002T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 2 LUDLOW PARK DR CHICOPEE MA 010221318 US 010221318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-20 |