MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-11 for REZUM D2201 manufactured by Medplast Medical, Inc..
[183129541]
Date of event the exact date of the event was not reported. The device is not available for analysis. A review of the rezum ifu and operators manual was completed and did not reveal any evidence of device misuse, off-label use, or failure to follow instructions. The potential cause and controls for complaints related to clinical events were identified. Based on review of the information available, pain is a known risk associated with the use of the device and is noted as such in the instruction for use (ifu). An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.
Patient Sequence No: 1, Text Type: N, H10
[183129542]
It was reported that a patient had a convective radiofrequency water vapor thermal therapy procedure and noted that he had pain and it hurt and did nothing. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937094-2020-00264 |
| MDR Report Key | 9821162 |
| Report Source | CONSUMER |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-03-11 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 | 2020-03-11 |
| Model Number | D2201 |
| Catalog Number | D2201 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-11 |