FDA Adverse Event
Injury
Summary report: N
NEOTRACT UROLIFT SYSTEM
MDR report key: 11815499
·
Received May 12, 2021
Report
- Report Number
- 3015181082-2021-00014
- Event Type
- Injury
- Date Received
- May 12, 2021
- Date of Event
- March 27, 2021
- Report Date
- May 12, 2021
- Manufacturer
- NEOTRACT, INC.
- Product Code
- PEW
- UDI-DI
- 00814932020001
- PMA / PMN Number
- K193269
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON 27 MARCH 2021, NEOTRACT WAS MADE AWARE OF A PATIENT THAT UNDERWENT A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2021. ON (B)(6) 2021, IT WAS REPORTED THAT ONE DAY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED HYPOTENSION AND URINARY BLEEDING. HE WAS TREATED AND RECEIVED A BLOOD TRANSFUSION. ON (B)(6) 2021, HE WAS DISCHARGED WITH A CATHETER AND IS REPORTED TO BE DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 708457 | NEOTRACT UROLIFT SYSTEM | UROLIFT SYSTEM | PEW | NEOTRACT, INC. | UROLIFT SYSTEM | P00042 | 00814932020001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |