MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,08 report with the FDA on 2011-11-01 for RUSCH MALONEY ESOPHAGEAL BOUGIE 215036 manufactured by Teleflex Medical.
[2316617]
The event is reported as: the surgeon accidentally pierced the bougie while suturing. When the bougie was removed it was leaking small amounts of tungsten. The pt was tested for heavy metal poisoning, which resulted in the findings being normal. Pt current condition is fine.
Patient Sequence No: 1, Text Type: D, B5
[9492159]
No sample is available for the mfr to evaluate. A follow-up report will be sent when investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2011-00449 |
| MDR Report Key | 2354051 |
| Report Source | 01,05,06,07,08 |
| Date Received | 2011-11-01 |
| Date of Report | 2011-10-18 |
| Date of Event | 2011-09-27 |
| Date Mfgr Received | 2011-10-18 |
| Date Added to Maude | 2012-05-02 |
| 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 | JASMINE BROWN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614124 |
| Manufacturer Street | PROLONGACION MISION EUSEBIO KINE #1316, RANCHO EL DESCANSO |
| Manufacturer City | TECATE B.C. 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| 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 | 2011-11-01 |
| Catalog Number | 215036 |
| Lot Number | UNK |
| 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 | TECATE MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-01 |