MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-07 for MEN'S LIBERTY 23046 manufactured by Bioderm, Inc..
[144394911]
Doctor's notes received. There is no confirmed reported history of infection related to our product. We are unable to confirm if the reported infection was caused by our device.
Patient Sequence No: 1, Text Type: N, H10
[144394912]
Patient's daughter contacted us that her father was treated for a uti with antibiotics, while using our product. Doctor's notes were requested, but we initially received prior notes indicating patient used a different type of catheter. Notes also indicate recurrent uti's and hospitalizations. Notes were received on (b)(6) 2019 for a hospitalization on (b)(6) 2019. Patient was admitted due to him requiring iv antibiotics for uti. Notes from the hospital doctor mention urinary tract infection with esbl, urinary incontinence and neurogenic bladder with external catheter, prior history of uti's, and that home health services such as nursing and therapy are "medically necessary".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001949129-2019-00003 |
| MDR Report Key | 8588505 |
| Date Received | 2019-05-07 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-03-04 |
| Date Mfgr Received | 2019-03-08 |
| Date Added to Maude | 2019-05-07 |
| 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 | 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 | 2019-05-07 |
| Model Number | 23046 |
| Lot Number | E05601 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-05-07 |