MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-06 for MEN'S LIBERTY 23046 manufactured by Bioderm, Inc..
[135417348]
Information was requested to his provider who stated that due to his history of urinary retention, he is at a higher risk for infection. Medical charts from provider's office confirms uti infection. Patient informed that urine was retested and it came out clear. No further issues reported. Patient is resuming daily activities. There is no confirmed reported history of uti related to our product. We are unable to confirm if the uti was caused by our device.
Patient Sequence No: 1, Text Type: N, H10
[135417349]
According to the patient, he experienced uti type symptoms and was hospitalized for 6 days with a confirmed uti he believes was cause by our product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001949129-2018-00001 |
| MDR Report Key | 8313196 |
| Date Received | 2019-02-06 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-10-17 |
| Date Mfgr Received | 2018-11-21 |
| Date Added to Maude | 2019-02-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 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 CT 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 | 2019-02-06 |
| Model Number | 23046 |
| Lot Number | D19701 |
| 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 | 2019-02-06 |