MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-12-13 for DAVOL MILLER-ABBOTT TUBE, 16 FR DC6028 manufactured by Davol, Inc..
[7491]
The device was placed in the pt. Mercury was added to the tube but was placed in the lumen that is open to the stomach allowing the mercury to escape. The mercury was extracted later using a gastroscope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 10826 |
| MDR Report Key | 10826 |
| Date Received | 1993-12-13 |
| Date of Report | 1993-11-18 |
| Date of Event | 1993-10-28 |
| Date Facility Aware | 1993-11-16 |
| Report Date | 1993-11-18 |
| Date Reported to FDA | 1993-11-18 |
| Date Added to Maude | 1994-01-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAVOL MILLER-ABBOTT TUBE, 16 FR |
| Generic Name | MILLER ABBOTT TUBE, 16 FR |
| Product Code | FEF |
| Date Received | 1993-12-13 |
| Catalog Number | DC6028 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10826 |
| Manufacturer | DAVOL, INC. |
| Manufacturer Address | CRANSTON RI 029200500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-12-13 |