MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-31 for REZUM D2201 manufactured by Boston Scientific Corporation.
| Report Number | 3001236349-2020-00011 |
| MDR Report Key | 9904695 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-13 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2019-12-02 |
| Date Added to Maude | 2020-03-31 |
| 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 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 017521242 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 017521242 |
| 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 | 2020-03-31 |
| Model Number | D2201 |
| Catalog Number | D2201 |
| Lot Number | 0024969314 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 017521242 US 017521242 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |