MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-16 for REZUM D2201 manufactured by Medplast Medical, Inc..
[183735275]
Treating physician: dr. (b)(6). Facility: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[183735276]
It was reported that from february 2016 to november 2018, the patient was seen by treating physician. The patient underwent cystoscopy on or about (b)(6) 2018 and diagnosed with enlarged median lobe. The patient underwent convective radiofrequency water vapor thermal therapy procedure of the prostate on (b)(6) 2018 and as results of care and/or treatment rendered, the patient sustained permanent injuries, disfigurement and illness (exact symptoms experienced were not provided). No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937094-2020-00294 |
| MDR Report Key | 9838309 |
| Report Source | CONSUMER |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-03-25 |
| Date Added to Maude | 2020-03-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ALYSON HARRIS |
| Manufacturer Street | 150 BAYTECH DRIVE |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal | 95134 |
| Manufacturer Phone | 4089353452 |
| Manufacturer G1 | MEDPLAST MEDICAL, INC. |
| Manufacturer Street | 5079 33RD STREET SE |
| Manufacturer City | GRAND RAPIDS MI 49512 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REZUM |
| Generic Name | UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) |
| Product Code | KNS |
| Date Received | 2020-03-16 |
| Model Number | D2201 |
| Catalog Number | D2201 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDPLAST MEDICAL, INC. |
| Manufacturer Address | 5079 33RD STREET SE GRAND RAPIDS MI 49512 US 49512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2020-03-16 |