MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-12-08 for MALONEY 60FR ESOPHAGEAL BOUGIE 215060 manufactured by Rusch, Inc..
[72618]
It was stated that the device was received on november 27,1997 and used for a procedure on november 28,1997. Today, after soaking the bougie, it was to be put away and a crack was noticed toward the tip of the bougie. No harm to pt and no apparent leaking of mercury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429473-1997-00116 |
| MDR Report Key | 137136 |
| Report Source | 06 |
| Date Received | 1997-12-08 |
| Date of Report | 1997-12-05 |
| Date of Event | 1997-12-05 |
| Date Mfgr Received | 1997-12-05 |
| Device Manufacturer Date | 1997-07-01 |
| Date Added to Maude | 1997-12-11 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALONEY 60FR ESOPHAGEAL BOUGIE |
| Generic Name | BOUGIE DIALATOR |
| Product Code | KCD |
| Date Received | 1997-12-08 |
| Model Number | NA |
| Catalog Number | 215060 |
| Lot Number | 725025 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 133958 |
| Manufacturer | RUSCH, INC. |
| Manufacturer Address | 2450 MEADOWBROOK PKWY. DULUTH GA 30096 US |
| Baseline Brand Name | MALONEY ESOPHAGEAL BOUGIE |
| Baseline Generic Name | BOUGIE DIALATOR |
| Baseline Model No | NA |
| Baseline Catalog No | 215060 |
| Baseline ID | NA |
| Baseline Device Family | MALONEY & HURST BOUGIE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-12-08 |