MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-22 for MEN'S LIBERTY 23046 manufactured by Bioderm, Inc..
[142736946]
Doctor's notes received. There is no confirmed reported history of infection related to our product. We are unable to confirm if the infection was caused by our device.
Patient Sequence No: 1, Text Type: N, H10
[142736947]
Patient contacted us on 3/26/19 saying he was treated for uti with antibiotics, while using our product. He had blood in urine. Doctor's notes dated a few days before ((b)(6) 2019) show he was treated for acute cystitis with hematuria, cloudy urine or dysuria, etiology unclear, and risk of uti versus chronic colonization or contamination of sample with catheterization. Other notes were received for doctor follow up on (b)(6) 2019. It says he was hospitalized (b)(6) 2019 - (b)(6) 2019. It was found he had an (b)(6) uti and was treated with antibiotics. Patient has a history of hematuria, prostate cancer, chemotherapy, and other health issues. He was wearing our device to treat incontinence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001949129-2019-00002 |
| MDR Report Key | 8537525 |
| Date Received | 2019-04-22 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-03-29 |
| Date Mfgr Received | 2019-04-11 |
| Date Added to Maude | 2019-04-22 |
| 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 | JULIE METZLER |
| Manufacturer Street | 12320 73RD COURT N. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7275077655 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEN'S LIBERTY |
| Generic Name | EXTERNAL CATHETER |
| Product Code | NOA |
| Date Received | 2019-04-22 |
| Model Number | 23046 |
| Lot Number | E00501 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIODERM, INC. |
| Manufacturer Address | 12320 73RD COURT N. LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-04-22 |