FDA Adverse Event
Injury
Summary report: N
REZUM DELIVERY DEVICE KIT FOR BPH
MDR report key: 8170230
·
Received December 17, 2018
Report
- Report Number
- 3007795803-2018-00003
- Event Type
- Injury
- Date Received
- December 17, 2018
- Date of Event
- December 1, 2018
- Report Date
- December 6, 2018
- Manufacturer
- NXTHERA INC.
- Product Code
- KNS
- PMA / PMN Number
- K180237
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
DATE OF THE EVENT: THE EXACT DATE IS UNKNOWN. DESCRIBE EVENT OR PROBLEM: CORRECTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT 6 MONTHS POST CONVECTIVE RADIO FREQUENCY WATER VAPOR THERMAL TREATMENT OF THE PROSTATE, THERE IS REMAINING NECROTIC TISSUE ON THE LEFT LATERAL LOBE. THE PHYSICIAN PERFORMED A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) BECAUSE THE PATIENT HAD TERRIBLE DYSURIA AND URGENCY. NO FURTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative · 1
DATE OF THE EVENT: THE EXACT DATE IS UNKNOWN.
Description of Event or Problem · 1
IT WAS REPORTED THAT 6 MONTHS POST CONVECTIVE RADIO FREQUENCY WATER VAPOR THERMAL TREATMENT OF THE PROSTATE, THERE IS REMAINING NECROTIC TISSUE ON THE LEFT LATERAL LOBE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1008713 | REZUM DELIVERY DEVICE KIT FOR BPH | VAPOR ABLATION SYSTEM | KNS | NXTHERA INC. | D2201-C2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |