FDA Adverse Event
Death
Summary report: N
NEOTRACT UROLIFT SYSTEM
MDR report key: 12284996
·
Received August 5, 2021
Report
- Report Number
- 3015181082-2021-00022
- Event Type
- Death
- Date Received
- August 5, 2021
- Report Date
- August 5, 2021
- Manufacturer
- NEOTRACT, INC.
- Product Code
- PEW
- UDI-DI
- 00814932020001
- PMA / PMN Number
- K193269
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON 9 JULY 2021, NEOTRACT WAS MADE AWARE OF A PUBLISHED ARTICLE THAT INCLUDED DETAILS OF A PATIENT WHO REPORTEDLY EXPERIENCED AN INFECTION WITHIN 30 DAYS OF A PROSTATIC URETHRAL LIFT (PUL) PROCEDURE, WHICH EVENTUALLY LED TO THE PATIENT PASSING ON AN UNSPECIFIED DATE. THE ARTICLE MENTIONED THAT SEPSIS WAS A CONTRIBUTING FACTOR TO THE PATIENT DEATH, BUT DID NOT SPECIFICALLY LINK THE SEPSIS EVENT TO THE PUL PROCEDURE. NEOTRACT HAS NO ADDITIONAL INFORMATION ON THE PATIENT¿S MEDICAL HISTORY OR COMORBIDITY FACTORS THAT LED TO THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1176715 | NEOTRACT UROLIFT SYSTEM | UROLIFT SYSTEM | PEW | NEOTRACT, INC. | UROLIFT SYSTEM | 00814932020001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |