MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-12-21 for FITEXTRALGZ manufactured by Medline Industries Inc..
[131139628]
It was reported that the end-user used the incontinence briefs since (b)(6) 2018 (approximately six months) and end-user developed "red, round, flat" rashes to the perineal area. Per report, end-user required use of nystatin (anti-fungal) cream and skin protectant pastes. Reportedly, the end-user has no known allergies. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further end-user, product, or procedural details. No information was provided on what product problem or device failure was experienced with the incontinence briefs leading to the end-user developing fungal rash. Due to the reported medical intervention, this medwatch is being filed. Samples are not available to be returned for evaluation. A root cause could not be established at this time. No additional information is available. If additional relevant information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[131139629]
It was reported that end-user developed fungal rash to the perineal area after using the incontinence briefs for six months.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00140 |
| MDR Report Key | 8189103 |
| Report Source | USER FACILITY |
| Date Received | 2018-12-21 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-09-18 |
| Date Mfgr Received | 2018-11-26 |
| Date Added to Maude | 2018-12-21 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | BRIEF,CLOTHLIKE,FITEXTRA,LG,48-58" |
| Product Code | EYQ |
| Date Received | 2018-12-21 |
| Catalog Number | FITEXTRALGZ |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-21 |