MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-04-20 for WRX279024 manufactured by Medline Industries, Inc..
[43081775]
It was reported that while using the device on each leg, the leg casts became wet and had to be replaced. The operative sites were not affected. The sample was returned and evaluated. The openings of both protectors had stretch marks around it suggesting that both had been used. Moisture could be observed on the outside of the devices but not on the inside. It is not known if the cast protectors were appropriately applied prior to use to prevent water from entering. There was no indication of a manufacturing defect. A root cause has not been determined. Due to the need for the casts to be replaced, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[43081776]
While using cast protectors bilaterally, both of the casts became wet and had to be replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2016-00042 |
| MDR Report Key | 5590596 |
| Report Source | CONSUMER |
| Date Received | 2016-04-20 |
| Date of Report | 2016-04-20 |
| Date of Event | 2016-03-22 |
| Date Mfgr Received | 2016-03-22 |
| Device Manufacturer Date | 2015-09-01 |
| Date Added to Maude | 2016-04-20 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DIANE CHRISTENSEN |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CAST PROTECTOR |
| Product Code | KIA |
| Date Received | 2016-04-20 |
| Catalog Number | WRX279024 |
| Lot Number | 90115090037 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-20 |