FDA Adverse Event
Injury
Summary report: N
NEOTRACT UROLIFT SYSTEM UL400
MDR report key: 8764578
·
Received July 5, 2019
Report
- Report Number
- 3005791775-2019-00023
- Event Type
- Injury
- Date Received
- July 5, 2019
- Date of Event
- May 30, 2019
- Report Date
- July 5, 2019
- Manufacturer
- NEOTRACT, INC.
- Product Code
- PEW
- UDI-DI
- 00814932020001
- PMA / PMN Number
- K173087
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON (B)(4) 2019, NEOTRACT INC. WAS NOTIFIED ABOUT A PATIENT THAT SUCCESSFULLY UNDERWENT A PUL PROCEDURE ON (B)(6) 2019. ADDITIONAL DETAILS RECEIVED ON (B)(6) 2019 FOUND THAT DURING THE EVENING OF (B)(6) 2019, THE PATIENT PRESENTED TO THE ER WITH COMPLAINTS OF HEMATURIA AND PAIN. THE PATIENT WAS ADMITTED AND RECEIVED A CATHETER WITH CONTINUOUS BLADDER IRRIGATION. ON (B)(6) 2019, HE UNDERWENT FULGURATION OF THE BLADDER NECK. ON (B)(6) 2019, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND REPORTED TO BE DOING WELL. THE PATIENT WAS HOSPITALIZED FOR A TOTAL OF 4 DAYS. IT WAS REPORTED THAT THE HEMATURIA AND PAIN RESOLVED BEFORE DISCHARGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 557064 | NEOTRACT UROLIFT SYSTEM UL400 | UROLIFT SYSTEM | PEW | NEOTRACT, INC. | UL400 | UNKNOWN | 00814932020001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | NO INFORMATION AVAILABLE. |