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..
[174943576]
Doctor's notes from hospital 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, and medical history/diagnosis of abscess could suggest otherwise. It is also unclear if he was using the device at the time of infection as he stated he stopped using the device because he couldn't get it to stay on him.
Patient Sequence No: 1, Text Type: N, H10
[174943577]
Patent was a new user (around (b)(6) 2019) and attempts for product follow up were made multiple times. Patient was reached on (b)(6) 2019. He reported that he was no longer using the men's liberty product as he couldn't get them to stay on. He also mention he was in the hospital for uti. Doctor's notes were requested that day, but not received. Hospital notes were requested instead on 11/12/2019. Printed copies of chart notes were received 12/23/2019 by mail. Notes were dated for doctor visits over the last year. Patient was hospitalized (b)(6) 2019 for uti and paroxysmal atrial fibrillation. A pelvic abscess near the bladder was also discovered, but too small for interventional radiology to drain. He was discharged from a rehabilitation center on (b)(6) 2019. No where in his notes is there a mention of an external catheter, and there were many notes of the patient using pads or diapers for incontinence treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001949129-2019-00007 |
| MDR Report Key | 9583343 |
| Report Source | CONSUMER |
| Date Received | 2020-01-13 |
| Date of Report | 2020-01-13 |
| Date of Event | 2019-10-06 |
| Date Mfgr Received | 2019-10-24 |
| 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 | E27401 |
| 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 |