MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-16 for MINIONE MI-5-1215 manufactured by Applied Medical Technology, Inc..
[117292098]
Patient presented to the emergency room from home, because button g-tube (12 fr 1. 5 cm) was out of the patient. The button g-tube was brought to the emergency room for examination. The balloon was determined to be ruptured. This tube only lasted 31 days. This is the 3rd g-tube balloon rupture for this patient. In addition, to this specific patient, we have six other confirmed patients that have had similar experiences with their g-tubes. The balloon failures were a tear and depletion of water. These events occurred within 30 days of insertion. Some of these events required an emergency room visit, reinsertion of the g-tube in the operating room and/or additional radiation exposure. Manufacturer response for gastrostomy low profile button tube, amt mini one button g-tube (per site reporter): your feedback is extremely important to us and i will forward this to our corporate office and will get back with you on monday if that is acceptable to you. The short answer is that we have not been experiencing or hearing of these issues in the midwest region which i manage but we are committed to finding a solution to improve clinical outcomes for your patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7788682 |
| MDR Report Key | 7788682 |
| Date Received | 2018-08-16 |
| Date of Report | 2018-07-20 |
| Date of Event | 2018-07-06 |
| Report Date | 2018-07-20 |
| Date Reported to FDA | 2018-07-20 |
| Date Reported to Mfgr | 2018-08-16 |
| Date Added to Maude | 2018-08-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | MINIONE |
| Generic Name | GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS |
| Product Code | PIF |
| Date Received | 2018-08-16 |
| Catalog Number | MI-5-1215 |
| Lot Number | 180529-374 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 31 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 8006 KATHERINE BOULEVARD BRECKSVILLE OH 44141 US 44141 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-16 |