MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-23 for LOUPE manufactured by Metrex Research Llc Dba Orascoptic, Surgical Acuit.
| Report Number | 3003848022-2019-00001 |
| MDR Report Key | 8928204 |
| Date Received | 2019-08-23 |
| Date of Report | 2019-08-23 |
| Date Mfgr Received | 2019-07-29 |
| Date Added to Maude | 2019-08-23 |
| 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 | MR. BRYAN SOWATZKE |
| Manufacturer Street | 6650 RONALD REAGAN AVE. |
| Manufacturer City | MADISON WI 53704 |
| Manufacturer Country | US |
| Manufacturer Postal | 53704 |
| Manufacturer Phone | 6088285223 |
| Manufacturer G1 | METREX RESEARCH LLC DBA ORASCOPTIC, SURGICAL ACUIT |
| Manufacturer Street | 6650 RONALD REAGAN AVE. |
| Manufacturer City | MADISON WI 53704 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53704 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LOUPE |
| Generic Name | SURGICAL HEADLIGHT |
| Product Code | EBA |
| Date Received | 2019-08-23 |
| Lot Number | 096435 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | METREX RESEARCH LLC DBA ORASCOPTIC, SURGICAL ACUIT |
| Manufacturer Address | 6650 RONALD REAGAN AVE. MADISON WI 53704 US 53704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-23 |