MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-04-18 for ARGYLE DENNIS TUBE UNKNOWN manufactured by Sherwood Med Co.
[18198503]
Pt with tube noted to have mercury in bowel on x-ray. Attributed to previous tube that pt self-removed that prior episode. At time of removal of this tube (3/4/95) pt noted to have more mercury in bowel. Md who removed tube noted that bag was ruptured, but removed intact (no fragments left) no harm/injury to pt per md as mercury is not absorbable & will pass through rectum.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005636 |
| MDR Report Key | 21219 |
| Date Received | 1995-04-18 |
| Date of Report | 1995-03-07 |
| Date of Event | 1995-03-04 |
| Date Added to Maude | 1995-04-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARGYLE DENNIS TUBE |
| Generic Name | MERCURY WEIGHTED NASOGASTRIC TUBE |
| Product Code | FEF |
| Date Received | 1995-04-18 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 21204 |
| Manufacturer | SHERWOOD MED CO |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-04-18 |