MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-30 for MINI ONE BALLOON BUTTON M1-5-1208 manufactured by Applied Medical Technology, Inc..
| Report Number | 1526012-2020-00002 |
| MDR Report Key | 9899437 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-09 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-30 |
| 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 | MR. JOSHUA MEINKE |
| Manufacturer Street | 8006 KATHERINE BOULEVARD |
| Manufacturer City | BRECKSVILLE, OH |
| Manufacturer Country | US |
| Manufacturer Phone | 7174000252 |
| Manufacturer G1 | APPLIED MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 8006 KATHERINE BOULEVARD |
| Manufacturer City | BRECKSVILLE, OH |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINI ONE BALLOON BUTTON |
| Generic Name | GASTROSTOMY TUBE |
| Product Code | KNT |
| Date Received | 2020-03-30 |
| Model Number | M1-5-1208 |
| Catalog Number | M1-5-1208 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 8006 KATHERINE BOULEVARD BRECKSVILLE, OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-30 |