MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-09-19 for AMT MINI ONE? ENTERAL EXTENSION SET 8-2455-ISOSAF manufactured by Applied Medical Technology, Inc..
| Report Number | 1526012-2019-00003 |
| MDR Report Key | 9087983 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-09-19 |
| Date of Report | 2019-09-16 |
| Date Mfgr Received | 2019-08-20 |
| Date Added to Maude | 2019-09-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SARAH BEERCHECK |
| Manufacturer Street | 8006 KATHERINE BLVD. |
| Manufacturer City | BRECKSVILE OH 44141 |
| Manufacturer Country | US |
| Manufacturer Postal | 44141 |
| Manufacturer Phone | 4402622541 |
| Manufacturer G1 | APPLIED MEDICAL TECHNOLOGY, INC |
| Manufacturer Street | 8006 KATHERINE BLVD |
| Manufacturer City | BRECKSVILLE OH 44141 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44141 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMT MINI ONE? ENTERAL EXTENSION SET |
| Generic Name | ENTERAL EXTENSION SET |
| Product Code | PIF |
| Date Received | 2019-09-19 |
| Model Number | 8-2455-ISOSAF |
| Lot Number | 190626-408 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 8006 KATHERINE BLVD. BRECKSVILLE OH 44141 US 44141 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-19 |