MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-07-14 for CANTOR TUBE 205100 manufactured by Willy Rusch, Ag.
[18473761]
It is alleged that a cantor tube was inserted and mercury instilled. A subsequent x-ray indicated the presence of mercury in the stomach.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 48207-1999-00066 |
| MDR Report Key | 231851 |
| Report Source | 06 |
| Date Received | 1999-07-14 |
| Date of Report | 1999-07-13 |
| Date of Event | 1998-09-20 |
| Date Mfgr Received | 1999-07-12 |
| Date Added to Maude | 1999-07-19 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CANTOR TUBE |
| Generic Name | INTESTINAL TUBE |
| Product Code | KDH |
| Date Received | 1999-07-14 |
| Model Number | NA |
| Catalog Number | 205100 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 224744 |
| Manufacturer | WILLY RUSCH, AG |
| Manufacturer Address | WILLY RUSCH STRASSE, 4-10 KERNEN GM 71394 |
| Baseline Brand Name | CANTOR TUBE |
| Baseline Generic Name | INTESTINAL TUBE |
| Baseline Model No | NA |
| Baseline Catalog No | 205100 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1999-07-14 |