MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-07 for GELPOINT MINI ADVANCED ACCESS PLATFORM manufactured by Applied Medical Resources Corp..
| Report Number | MW5087222 |
| MDR Report Key | 8683765 |
| Date Received | 2019-06-07 |
| Date of Report | 2019-06-05 |
| Date of Event | 2019-05-14 |
| Date Added to Maude | 2019-06-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GELPOINT MINI ADVANCED ACCESS PLATFORM |
| Generic Name | CULDOSCOPE (AND ACCESSORIES) |
| Product Code | HEW |
| Date Received | 2019-06-07 |
| Lot Number | 1348491 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES CORP. |
| Manufacturer Address | RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-06-07 |