MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-02-06 for "WARMERS, INFANT HEEL W/TABS" MH00002T manufactured by Covidien.
[135156805]
The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Patient Sequence No: 1, Text Type: N, H10
[135156806]
The customer reported the heel warmer broke after activation and leaked onto the patient. There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219103-2019-00222 |
| MDR Report Key | 8310138 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-02-06 |
| Date of Report | 2019-02-27 |
| Date of Event | 2019-01-17 |
| Date Mfgr Received | 2019-01-17 |
| Date Added to Maude | 2019-02-06 |
| 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 | 5084524970 |
| 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 | 2019-02-06 |
| Model Number | MH00002T |
| Catalog Number | MH00002T |
| Lot Number | UNKNOWN |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2019-02-06 |