FDA Adverse Event
Injury
Summary report: N
NEOTRACT UROLIFT SYSTEM
MDR report key: 11726654
·
Received April 26, 2021
Report
- Report Number
- 3015181082-2021-00012
- Event Type
- Injury
- Date Received
- April 26, 2021
- Date of Event
- March 18, 2021
- Report Date
- April 26, 2021
- Manufacturer
- NEOTRACT, INC.
- Product Code
- PEW
- UDI-DI
- 00814932020001
- PMA / PMN Number
- K193269
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON (B)(6) 2021, NEOTRACT WAS MADE AWARE OF A PATIENT THAT UNDERWENT A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2021. AFTER THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEMATURIA AND BLOOD CLOTS. ON (B)(6) 2021, NEOTRACT WAS MADE AWARE THAT HE UNDERWENT CAUTERIZATION FOR CONTINUED BLEEDING. THE PATIENT REPORTS HE NO LONGER EXPERIENCES HEMATURIA, BUT CONTINUES TO USE INTERMITTENT CATHETERS FOR URINARY RETENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 621940 | NEOTRACT UROLIFT SYSTEM | UROLIFT SYSTEM | PEW | NEOTRACT, INC. | UROLIFT SYSTEM | UNKNOWN | 00814932020001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |