MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-08-06 for CAST AND BANDAGE PROTECTOR CUR200ALL manufactured by Medline Industries, Inc..
[4958722]
The dressing became wet while showering and the apligraf was replaced.
Patient Sequence No: 1, Text Type: D, B5
[11933868]
Apligraf had been applied to a left foot wound one month prior to the incident. Last month while showering, the end user stated he felt water inside the protector. His dressing became wet and the apligraf on his foot had to be reapplied. The protector was not returned to use for eval. It is not known if it was applied correctly or if there was any damage to the protector prior to or during use. A root cause has not been determined. We have not confirmed that a defect existed but in an abundance of caution this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00076 |
| MDR Report Key | 4006329 |
| Report Source | 04 |
| Date Received | 2014-08-06 |
| Date of Report | 2014-08-06 |
| Date of Event | 2014-07-01 |
| Date Mfgr Received | 2014-07-11 |
| Date Added to Maude | 2014-08-14 |
| 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 AND BANDAGE PROTECTOR |
| Product Code | KIA |
| Date Received | 2014-08-06 |
| Catalog Number | CUR200ALL |
| 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. Required No Informationntervention | 2014-08-06 |