MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-07-18 for RUSCH MALONEY ESOPHAGEAL BOUGIE 58F 215058 manufactured by Teleflex Medical.
[2833316]
The event is reported as: alleged issue: during an ent procedure, the bougie was caught at the end of a laryngoscope and some of the black contents from the bougie burst inside the pt. " no pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[10054941]
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. No conclusion can be established at this time based on the lack of defective sample. It is necessary to have the physical sample in order to perform a proper investigation. The manufacturer will continue to monitor and trend relating complaints.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2012-00244 |
| MDR Report Key | 2672065 |
| Report Source | 05,06 |
| Date Received | 2012-07-18 |
| Date of Report | 2012-07-02 |
| Date of Event | 2012-07-02 |
| Date Mfgr Received | 2012-07-05 |
| Date Added to Maude | 2012-11-06 |
| 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 G1 | TELEFLEX |
| Manufacturer Street | AVE. TRANSFORMACION 5954 PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH MALONEY ESOPHAGEAL BOUGIE 58F |
| Generic Name | ESOPHAGEAL BOUGIE |
| Product Code | KCD |
| Date Received | 2012-07-18 |
| Catalog Number | 215058 |
| Operator | OTHER |
| 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 | 2012-07-18 |