MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-01-09 for RUSCH HURST ESOPHAGEAL BOUGIE 3 215532 manufactured by Teleflex Medical.
[21237533]
The complaint was reported as: alleged issue: a pt was having a medical procedure using a maloney rusch tungsten filled bougie and the doctor cut it with a stapling instrument where the tungsten came out into the pt. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[21298916]
Device sample has not been received by manufacturer in time for this report. A device history record (dhr) review could not be conducted since the lot number was not provided. No corrective action can be established since the defective sample was not received for evaluation. As a preventive action the involved production and quality personnel were informed about this complaint. No conclusion can be established at this time based on the lack of defective sample. Based on the description of the complaint it was stated that the doctor cut it with a stapling instrument therefore it is unknown the method used by customer. It is necessary to have the physical sample in order to perform a proper investigation. This complaint was notified to the personnel involved on the manufacturing process. Manufacturer will continue to monitor and trend relating complaints.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2014-00013 |
| MDR Report Key | 3769248 |
| Report Source | 05,06 |
| Date Received | 2014-01-09 |
| Date of Report | 2013-12-23 |
| Date of Event | 2013-12-23 |
| Date Mfgr Received | 2013-12-23 |
| Date Added to Maude | 2014-05-22 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JAS,OME BROWN |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614124 |
| Manufacturer Street | AVE. TRANSFORMACION 5954 PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH HURST ESOPHAGEAL BOUGIE 3 |
| Generic Name | BOUGIE |
| Product Code | KCD |
| Date Received | 2014-01-09 |
| Catalog Number | 215532 |
| 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 MEDICAL |
| Manufacturer Address | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-09 |