MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-01-01 for MILLER ABBOTT TUBE 6028 manufactured by Davol, Inc..
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Tube inserted on 12/23/95. A fluoroscopy was done to check placement. Fluoroscopy demonstrated leakage of metallic mercury. On 12/23/95 an esophagastroduodenoscopy was performed to evacuate the mercury. A small quantity of very fine grain mercury remained in the stomach following the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 30536 |
| MDR Report Key | 30536 |
| Date Received | 1996-01-01 |
| Date of Report | 1995-12-27 |
| Date of Event | 1995-12-23 |
| Date Facility Aware | 1995-12-23 |
| Report Date | 1995-12-27 |
| Date Reported to FDA | 1995-12-29 |
| Date Reported to Mfgr | 1995-12-29 |
| Date Added to Maude | 1996-03-01 |
| 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 | MILLER ABBOTT TUBE |
| Generic Name | MILLER ABBOTT TUBE |
| Product Code | FEF |
| Date Received | 1996-01-01 |
| Model Number | 6028 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 31599 |
| Manufacturer | DAVOL, INC. |
| Manufacturer Address | 100 SOCKANOSSETT CROSSRD CRANSTON RI 02920 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-01-01 |