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..
[145772829]
It was initially reported that customer contact developed urinary tract infection related to use of bladder control pads. Per report, after the customer contact was told by her doctor to not use the bladder control pads since this resulted in urinary tract infection, customer contact gave the remaining bladder control pads to her granddaughter. Reportedly, the customer contact's granddaughter also developed urinary tract infection, which required unknown antibiotic therapy. Despite good faith efforts to obtain additional information, the initial reporter was unable or unwilling to provide any further information about her granddaughter, product, or event details. The customer contact stated that her granddaughter is doing well 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
[145772831]
It was reported that end-user developed urinary tract infection related to use of bladder control pads.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00051 |
| MDR Report Key | 8508911 |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-12 |
| Date Mfgr Received | 2019-04-04 |
| 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 |