MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-04-12 for HURST BOUGIE OR DILATOR CGD 38 FR manufactured by Pilling Co..
[10626]
During surgical procedure "exploratory thoracotomy, vagotomy, repair hernia, liver biopsy," an intact bougie was inserted per anesthetist. On removal leakage was noted from the bougie. This was reported to the surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001545 |
| MDR Report Key | 12686 |
| Date Received | 1994-04-12 |
| Date Added to Maude | 1994-04-13 |
| 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 |
| 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 | HURST BOUGIE OR DILATOR |
| Generic Name | BOUGIE OR DILATOR |
| Product Code | FAT |
| Date Received | 1994-04-12 |
| Catalog Number | CGD 38 FR |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 12686 |
| Manufacturer | PILLING CO. |
| Manufacturer Address | FORT WASHINGTON PA 19034 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-04-12 |