MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-10-16 for CAST PROTECTOR WRX279024 manufactured by Medline Industries, Inc..
[4963009]
While using the cast protector, the cast became wet and had to be replaced.
Patient Sequence No: 1, Text Type: D, B5
[12488689]
It was reported that while using the device, the leg cast became wet and had to be replaced. Some skin irritation of the heel was noted when the original cast was removed. The end user's mother tested the cast protector for leaks following the incident and none were found. The sample was not returned for evaluation. We have no lot number. A sample was pulled from stock and evaluated. No abnormalities were identified. It is not known if the top opening of the cast protector was appropriately secured prior to use to prevent water from entering. There is no indication that the incident was caused by a manufacturing defect. Without the actual sample a root cause has not been confirmed. Due to the need for the cast to be replaced, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00095 |
| MDR Report Key | 4196863 |
| Report Source | 04 |
| Date Received | 2014-10-16 |
| Date of Report | 2014-10-14 |
| Date of Event | 2014-09-24 |
| Date Mfgr Received | 2014-09-25 |
| Date Added to Maude | 2014-10-24 |
| 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 | CAST PROTECTOR |
| Product Code | KIA |
| Date Received | 2014-10-16 |
| Catalog Number | WRX279024 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2014-10-16 |