MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-13 for COMFORTPMMD manufactured by Medline Industries Inc..
[126913734]
It was reported that the end-user experienced skin breakdown and required an unidentified procedure. After multiple good-faith attempts, the facility contact was unable or unwilling to provide additional patient, product, or procedural information related to the reported incident. The reason for use and the frequency of change of the product is unknown. The location of the reported skin breakdown or the length of time between its discovery and the unidentified procedure is unknown. No additional intervention or follow-up care was reported to the manufacture. No sample was returned to the manufacturer for evaluation. A root cause could not be determined. Due to the reported incident, the need for the unidentified procedure, 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
[126913735]
It was reported that the end-user experienced skin breakdown and required an unidentified procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00123 |
| MDR Report Key | 8063839 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-13 |
| Date of Report | 2018-11-13 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-10-19 |
| Date Added to Maude | 2018-11-13 |
| 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 | BRIEF,OVERNIGHT,MD,32"-44",81CM-112CM |
| Product Code | EYQ |
| Date Received | 2018-11-13 |
| Catalog Number | COMFORTPMMD |
| 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; 2. Required No Informationntervention | 2018-11-13 |