MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-31 for MINIONE GT EXTENSION manufactured by Applied Medical Technology (amt), Inc..
| Report Number | MW5088657 |
| MDR Report Key | 8855720 |
| Date Received | 2019-07-31 |
| Date of Report | 2019-07-29 |
| Date Added to Maude | 2019-08-02 |
| 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 | 0 |
| Brand Name | MINIONE GT EXTENSION |
| Generic Name | GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS |
| Product Code | PIF |
| Date Received | 2019-07-31 |
| Lot Number | 190626-408 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL TECHNOLOGY (AMT), INC. |
| Manufacturer Address | BRECKSVILLE OH 44141 US 44141 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-31 |