MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-02-14 for MEN'S LIBERTY 23046 manufactured by Bioderm, Inc..
[136188791]
Requesting doctor's notes from hospital. Medical charts from provider's office. Attachment included. 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. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[136188792]
In (b)(6), patient claims while using our product, he noticed burning and stopped using. He says he was prescribed 10 days antibiotics and doctors found a kidney stone. Patient further describes he went to the hospital due to the infection and spent most of the holidays there ((b)(6)). He says that infection went to kidneys, also a kidney stone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001949129-2019-00001 |
| MDR Report Key | 8340415 |
| Report Source | CONSUMER |
| Date Received | 2019-02-14 |
| Date of Report | 2019-01-08 |
| Date Mfgr Received | 2019-01-08 |
| Date Added to Maude | 2019-02-14 |
| 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 | 2019-02-14 |
| Model Number | 23046 |
| Lot Number | D32001 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-02-14 |