MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-05 for MDS138007 manufactured by Medline Industries Inc..
[177807361]
It was reported that the temperature of the heel warmer was found to be "high" and when the heel warmer was used the patient experienced a burn. Despite multiple good faith attempts the reporting facility was unable or unwilling to provide additional information to manufacturer. It is unknown how the heel warmer was activated, how a temperature was identified to be "high," or how long the heel warmer was in use for prior to identifying the reported burn. No sample was returned to the manufacturer for evaluation. Temperature testing was performed on retained samples from the reported lot and from additional mds138007 lots. The product tested met temperature specifications. A root cause for the reported incident is unable to be determined. Due to the reported burn, and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[177807362]
It was reported that a heel warmer was used and that a patient experienced a burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2020-00004 |
| MDR Report Key | 9671043 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-01-14 |
| Date Added to Maude | 2020-02-05 |
| 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 | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 600932753 |
| Manufacturer Country | US |
| Manufacturer Postal | 600932753 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | WARMER,HEEL,INFANT,GEL PK,100CS |
| Product Code | MPO |
| Date Received | 2020-02-05 |
| Catalog Number | MDS138007 |
| Lot Number | VN19225B2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 600932753 US 600932753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-05 |