MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-13 for MEN'S LIBERTY 23046 manufactured by Bioderm, Inc..
[174895920]
Doctor's notes from a follow up only were received. There is no confirmed history of infection related to our product. We are unable to confirm if the infection was caused by our device, as patient/caregiver failed to follow instructions for use as they were using absorbent products with the device, and the cause is not established. Hospitalization is also not confirmed.
Patient Sequence No: 1, Text Type: N, H10
[174895921]
Patent was a new user (around (b)(6) 2019). Patient's wife reported that he was in the hospital for uti on (b)(6) 2019. Hospital notes were requested multiple times, but not received. Doctor's notes were requested and received instead on (b)(6) 2019. The notes were dated (b)(6) 2019 for follow up of urosepsis and antibiotic use. Notes mention he is doing much better and has urinary incontinence due to dementia. Diagnosis is listed as acute cystitis with hematuria. Notes mention that when he is back to base line he can continue with external catheter, monitor mental status, and look for signs of reoccurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001949129-2019-00008 |
| MDR Report Key | 9583321 |
| Report Source | CONSUMER |
| Date Received | 2020-01-13 |
| Date of Report | 2020-01-13 |
| Date of Event | 2019-10-27 |
| Date Mfgr Received | 2019-11-06 |
| Date Added to Maude | 2020-01-13 |
| 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 | 3 |
| Brand Name | MEN'S LIBERTY |
| Generic Name | EXTERNAL CATHETER |
| Product Code | NOA |
| Date Received | 2020-01-13 |
| Model Number | 23046 |
| Lot Number | E23001 |
| 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 | 2020-01-13 |