MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-13 for GELPOINT MINI ADVANCE ACCESS PLATFORM manufactured by Applied Medical.
[92043612]
Gelpoint mini product broke while in use by the physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073319 |
| MDR Report Key | 7027727 |
| Date Received | 2017-11-13 |
| Date of Report | 2017-11-10 |
| Date Added to Maude | 2017-11-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | GELPOINT MINI ADVANCE ACCESS PLATFORM |
| Generic Name | GELPOINT MINI |
| Product Code | HEW |
| Date Received | 2017-11-13 |
| Lot Number | 1300433 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL |
| Manufacturer Address | RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-13 |