MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-11-21 for ZIPWIRE HYDROPHILIC GUIDEWIRE M006630222B1 630-222B manufactured by Lake Region Medical.
| Report Number | 2126666-2019-00082 |
| MDR Report Key | 9354814 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-11-21 |
| Date of Report | 2019-11-21 |
| Date of Event | 2019-10-28 |
| Date Mfgr Received | 2019-11-04 |
| Device Manufacturer Date | 2019-03-19 |
| Date Added to Maude | 2019-11-21 |
| 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 | SHARON SEIFERT |
| Manufacturer Street | 340 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal | 55318 |
| Manufacturer Phone | 9526418518 |
| Manufacturer G1 | LAKE REGION MEDICAL |
| Manufacturer Street | 340 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIPWIRE HYDROPHILIC GUIDEWIRE |
| Generic Name | UROLOGICAL CATHETER AND ACCESSORIES |
| Product Code | EZB |
| Date Received | 2019-11-21 |
| Returned To Mfg | 2019-11-19 |
| Model Number | M006630222B1 |
| Catalog Number | 630-222B |
| Lot Number | 11133001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LAKE REGION MEDICAL |
| Manufacturer Address | 340 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-21 |