MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-06-17 for CAST PROTECTOR CUR200ALL manufactured by Medline Industries, Inc..
[3516404]
While using the cast protector, the cast became wet and had to be replaced.
Patient Sequence No: 1, Text Type: D, B5
[10747778]
It was reported that while using the device, the cast became wet and the cast had to be replaced. The cast protector was returned for evaluation. There were no rips, defects, tears or sealing issues of the material. The elastic opening did not display any signs of permanent deformation or breakdown. It is not known if the cast protector was sized correctly for the end user or if it had been applied correctly prior to use. There was no indication the incident was caused by a manufacturing defect. 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 | 1417592-2013-00053 |
| MDR Report Key | 3188065 |
| Report Source | 08 |
| Date Received | 2013-06-17 |
| Date of Report | 2013-06-13 |
| Date of Event | 2013-05-14 |
| Date Mfgr Received | 2013-05-16 |
| Device Manufacturer Date | 2012-09-01 |
| Date Added to Maude | 2013-06-26 |
| 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 | 3 |
| 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 | 2013-06-17 |
| Catalog Number | CUR200ALL |
| Lot Number | 26007083 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-06-17 |