MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-08-06 for MEN'S LIBERTY 23046 manufactured by Bioderm, Inc..
| Report Number | 3001949129-2019-00005 |
| MDR Report Key | 8864046 |
| Report Source | CONSUMER |
| Date Received | 2019-08-06 |
| Date of Report | 2019-08-01 |
| Date of Event | 2019-06-01 |
| Date Mfgr Received | 2019-07-08 |
| Date Added to Maude | 2019-08-06 |
| 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 | 3 |
| Brand Name | MEN'S LIBERTY |
| Generic Name | EXTERNAL CATHETER |
| Product Code | NOA |
| Date Received | 2019-08-06 |
| Model Number | 23046 |
| Lot Number | E13301 |
| 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 | 2019-08-06 |