MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2015-04-16 for WHEELCHAIR CONTOUR CUSHION MSCCONPL2418 manufactured by Medline Industries, Inc..
[5660948]
It was reported that the end user developed two stage ii lesions while sitting on the cushion.
Patient Sequence No: 1, Text Type: D, B5
[13270006]
It was reported that the end user developed two stage ii pressure ulcers while using this cushion. There was one on each buttock. He was treated with a topical antibacterial ointment with good results. It is unk how often skin assessments were done or how often the end user was repositioned. He has been utilizing this cushion on both a wheelchair and on a recliner since (b)(6) 2013. His nutritional status is unk. The sample was returned and evaluated and no manufacturing defects were found. We cannot confirm that the device caused the reported tissue injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2015-00033 |
| MDR Report Key | 4713462 |
| Report Source | 04,05 |
| Date Received | 2015-04-16 |
| Date of Report | 2015-04-14 |
| Date of Event | 2015-03-16 |
| Date Mfgr Received | 2015-03-17 |
| Date Added to Maude | 2015-04-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WHEELCHAIR CONTOUR CUSHION |
| Product Code | IMP |
| Date Received | 2015-04-16 |
| Catalog Number | MSCCONPL2418 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-16 |