MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2020-01-23 for "WARMERS, INFANT HEEL W/TABS" MH00002T manufactured by Covidien.
[176417871]
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.
Patient Sequence No: 1, Text Type: N, H10
[176417872]
The customer reported that the heel warmer pouch was breaking open and contents exploding out of the package.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219103-2020-00250 |
| MDR Report Key | 9622505 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2020-01-23 |
| Date of Report | 2020-01-23 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-01-21 |
| Date Added to Maude | 2020-01-23 |
| 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 | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5086183640 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 2 LUDLOW PARKWAY |
| Manufacturer City | CHICOPEE MA 01022 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01022 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | "WARMERS, INFANT HEEL W/TABS" |
| Generic Name | INFANT HEEL WARMER (CHEMICAL HEAT PACK) |
| Product Code | MPO |
| Date Received | 2020-01-23 |
| Model Number | MH00002T |
| Catalog Number | MH00002T |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 2 LUDLOW PARKWAY CHICOPEE MA 01022 US 01022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-23 |