MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-05-05 for MALONEY TUNGSTEN FILLED BOUGIE 34F 507934 manufactured by Teleflex.
[20972289]
It was reported that the device rolled itself into the stomach and when the surgeon tried to remove it, the tip was blocked inside the staples and the tip of the device broke off. The tip and the rest of the bougie was recovered. Another bougie was used. No other issue. The patient is fine. No consequence.
Patient Sequence No: 1, Text Type: D, B5
[21274563]
The device sample was not received by the manufacturer at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2014-00191 |
| MDR Report Key | 3868431 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-05-05 |
| Date of Report | 2014-04-07 |
| Date of Event | 2014-04-07 |
| Date Mfgr Received | 2014-04-07 |
| Date Added to Maude | 2014-06-27 |
| 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 | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | EFFIE JEFFERSON, RN |
| Manufacturer Street | 4024 STIRRUP CREEK DRIVE STE #720 |
| Manufacturer City | DURHAM NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal | 27703 |
| Manufacturer Phone | 9194332672 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALONEY TUNGSTEN FILLED BOUGIE 34F |
| Product Code | KCD |
| Date Received | 2014-05-05 |
| Catalog Number | 507934 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-05 |