MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-01-11 for HURST ESOPHAGEAL BOUGIE 30 FR 215530 manufactured by Teleflex Medical.
[1412297]
The event is reported as: during a surgical procedure, while using the device, the bougie was accidently stapled causing it to split open which resulted in the tungsten spilling into the pt's stomach. It was indicated the bougie was stapled approximately 3/4 of the way from the end. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[8428225]
The device has not been returned for investigation yet. A f/u investigation report will be sent when completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2010-00001 |
| MDR Report Key | 1586567 |
| Report Source | 06 |
| Date Received | 2010-01-11 |
| Date of Report | 2009-12-21 |
| Date of Event | 2009-12-21 |
| Date Mfgr Received | 2009-12-21 |
| Date Added to Maude | 2010-04-08 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANGELA BROWN, MANAGER |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334901 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HURST ESOPHAGEAL BOUGIE 30 FR |
| Generic Name | ESOPHAGEAL BOUGIE |
| Product Code | KCD |
| Date Received | 2010-01-11 |
| Model Number | NA |
| Catalog Number | 215530 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-01-11 |