MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-20 for UROLIFT SYSTEM FOR BPH TREATMENT NOT PROVIDED BY MD NOT PROVIDED manufactured by Neotract Inc..
[145784111]
Urolift implants were placed in through urinary tract. Was told removed same way. Md informed me he has never reversed procedure and must be surgically removed. Became immediately chronic. Infected and hospitalized to save life. Painful device prevents use of numerous prescribed meds, and otc product can't use many antibiotic meds to fight infection and feel product and / or removal would be life threatening. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086783 |
| MDR Report Key | 8627780 |
| Date Received | 2019-05-20 |
| Date of Report | 2019-05-16 |
| Date of Event | 2017-12-29 |
| Date Added to Maude | 2019-05-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UROLIFT SYSTEM FOR BPH TREATMENT |
| Generic Name | IMPLANTABLE, TRANSPROSTATIC TISSUE RETRACTOR SYSTEM |
| Product Code | PEW |
| Date Received | 2019-05-20 |
| Model Number | NOT PROVIDED BY MD |
| Catalog Number | NOT PROVIDED |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOTRACT INC. |
| Manufacturer Address | PLEASANTON CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other | 2019-05-20 |