MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-11 for REZUM D2201 manufactured by Medplast Medical, Inc..
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It was reported that, via a social media blog, a patient reported to have undergone a rezum prostate therapy procedure on (b)(6) 2020. The patient stated that the doctor put in a catheter and a urine holding bag; after one week it was taken out, however, the patient still could not urinate on his own. The physician put a catheter back for another week but the urination issue continued. The physician catheterized the patient again, this time for two weeks. The patient reported having seen the physician on (b)(6) 2020. The patient reported that the physician wants to rasp prostate tissue and patient is reluctant to get this done. The patient also reported that he is reverting back to the original problem and is passing a bit of urine in bed at night.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937094-2020-00251 |
| MDR Report Key | 9821558 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-01-09 |
| 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; 2. Required No Informationntervention | 2020-03-11 |