MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-10-16 for COMFORTAIRELG manufactured by Medline Industries, Inc..
[123871472]
It was reported that end-user developed urinary tract infection from the whitish powder on the pads of the adult briefs. The end-user reportedly received the adult diapers with whitish powder last (b)(6) 2018. Per report, the end-user went to an emergency department last (b)(6) 2018 and was told she has urinary tract infection. An unknown antibiotic was reportedly prescribed. Reportedly, a month later, the end-user continues to receive adult diapers with whitish powder on the pads and end-user developed another incident of urinary tract infection, which was treated with oral ciprofloxacin antibiotic. Due to the reported medical intervention, this medwatch is being filed. Samples were returned for evaluation and the complaint of whitish powder cannot be confirmed. No linting, sap or whitish powder was noted on the top sheet of the adult briefs. A root cause could not be determined at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[123871473]
It was reported that end-user developed urinary tract infection from the whitish powder on the pads of the adult briefs. Oral antibiotic treatment was required for the reported uti.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00115 |
| MDR Report Key | 7970435 |
| Report Source | CONSUMER |
| Date Received | 2018-10-16 |
| Date of Report | 2018-10-16 |
| Date of Event | 2018-07-01 |
| Date Mfgr Received | 2018-09-12 |
| Date Added to Maude | 2018-10-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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,COMFORTAIRE,CLOTHLIKE,LG,48-58" |
| Product Code | EYQ |
| Date Received | 2018-10-16 |
| Returned To Mfg | 2018-10-15 |
| Catalog Number | COMFORTAIRELG |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Generic Name | BRIEF,COMFORTAIRE,CLOTHLIKE,LG,48-58" |
| Product Code | EYQ |
| Date Received | 2018-10-16 |
| Returned To Mfg | 2018-10-15 |
| Catalog Number | COMFORTAIRELG |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-10-16 |