MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-12 for MSC327100Z manufactured by Medline Industries Inc..
[145772634]
It was reported by end user that she developed urinary tract infection related to use of bladder control pads. Per report, the end user had been receiving bladder control pads since 2017 from her insurance and had never experienced infection related to use of these pads in the past. The end-user stated that for approximately a month, she used bladder control pads from a specific case (lot number unknown) and then she started developing itching and burning during urination. Per end user, she changes her bladder control pads every two hours. On (b)(6) 2019, the end-user reportedly went to a doctor who told her she has urinary tract infection and this was caused by the bladder control pads. The end-user took an unknown antibiotic for seven days and she stopped using the suspected bladder control pads. The end user reported that she is doing well right now. Due to the reported urinary tract infection and required medical intervention, this medwatch is being filed. The sample is not available to be returned for evaluation. The complaint could not be confirmed and a definitive 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
[145772635]
It was reported by end user that she developed urinary tract infection related to use of bladder control pads.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00050 |
| MDR Report Key | 8508809 |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-12 |
| Date of Event | 2019-03-14 |
| Date Mfgr Received | 2019-03-21 |
| Date Added to Maude | 2019-04-12 |
| 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 | 0 |
| Generic Name | LINER,INCONTINENT,ULTRAPLUS,3.25"X13" |
| Product Code | EYQ |
| Date Received | 2019-04-12 |
| Catalog Number | MSC327100Z |
| 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 | 2019-04-12 |