MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-09-18 for RUSCH MALONEY ESOPHAGEAL BOUGIE 215038 manufactured by Teleflex Medical.
[916685]
Incident reported as: hospital reported that the product leaked a "slight" amount of tungsten into the patient. The patient is fine. The patient's esophagus and mouth were flushed and no patient injury was noted. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
[8239925]
No sample available for evaluation. Investigation is ongoing and an investigation report will follow when finished.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2008-00046 |
| MDR Report Key | 1166064 |
| Report Source | 06 |
| Date Received | 2008-09-18 |
| Date of Report | 2008-07-07 |
| Date Mfgr Received | 2008-07-07 |
| Date Added to Maude | 2009-04-23 |
| 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 | 4024 STIRRUP CREEK DRIVE |
| Manufacturer City | DURHAM NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal | 27703 |
| Manufacturer Phone | 9194334901 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | AVE. TRANSFORACION #512 PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO, TAMAULIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH MALONEY ESOPHAGEAL BOUGIE |
| Generic Name | ESOPHAGEAL BOUGIE |
| Product Code | KCD |
| Date Received | 2008-09-18 |
| Catalog Number | 215038 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | NUEVO LAREDO, TAMAULIPAS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-18 |