MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-01-05 for MALONEY ESPOHAGEAL BOUGIE 215028 manufactured by Rusch, Inc..
[204625]
It is reported that the tip of the bougie broke off during use. Distal end was not retreived at the time of the event. Upon removal of the device, it was noted that mercury was leaking from the broken end of the tube.
Patient Sequence No: 1, Text Type: D, B5
[17028211]
It is reported that the tip of the bougie broke off during use. Distal end was not retreived at the time of the event. Upon removal of the device, it was noted that mercury was leaking from the broken end of the tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429473-1999-00099 |
| MDR Report Key | 257979 |
| Report Source | 05 |
| Date Received | 2000-01-05 |
| Date of Report | 1999-12-21 |
| Date of Event | 1999-12-17 |
| Date Mfgr Received | 1999-12-17 |
| Date Added to Maude | 2000-01-12 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KATRINA HALBIG, QUALITY ADMIN. |
| Manufacturer Street | 2450 MEADOWBROOK PKWY. |
| Manufacturer City | DULUTH GA 30096 |
| Manufacturer Country | US |
| Manufacturer Postal | 30096 |
| Manufacturer Phone | 7706230816 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALONEY ESPOHAGEAL BOUGIE |
| Generic Name | ESOPHAGEAL BOUGIE |
| Product Code | KCD |
| Date Received | 2000-01-05 |
| Model Number | NA |
| Catalog Number | 215028 |
| Lot Number | 53694 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 249817 |
| Manufacturer | RUSCH, INC. |
| Manufacturer Address | 2450 MEADOWBROOK PKWY. DULUTH GA 30096 US |
| Baseline Brand Name | MALONEY ESOPHAGEAL BOUGIE |
| Baseline Generic Name | ESOPHAGEAL BOUGIE |
| Baseline Model No | NA |
| Baseline Catalog No | 215028 |
| Baseline ID | NA |
| Baseline Device Family | ESOPHAGEAL BOUGIE |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-01-05 |