MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-09-10 for BOUGIE manufactured by Medovations.
[17264063]
Pt underwent repair of a large incarcerated paraesophageal hernia. While passing 24f bougie down esophagus, a perforation was noted. Procedure was converted from laparoscopic to open approach.
Patient Sequence No: 1, Text Type: D, B5
[17454051]
Hospital was unable to provide exact part number and lot number of 24fr bougie and part was not returned for eval. A review of shipment records to this customer shows the likely device to be part number 1208-24 and lot number 212841, shipped on (b)(4) 2012. The bougies are a reusable devices, labeled with a 3 year expiration date. Pt esophageal perforation was repaired with 4 sutures during open approach of hernia repair procedure. Pt did not receive any additional treatment. There was no malfunction of the device and the device did not cause or contribute to the injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183446-2014-00001 |
| MDR Report Key | 4080746 |
| Report Source | 06 |
| Date Received | 2014-09-10 |
| Date of Report | 2014-04-30 |
| Date of Event | 2014-04-22 |
| Date Facility Aware | 2014-04-23 |
| Report Date | 2014-04-30 |
| Date Reported to Mfgr | 2014-04-30 |
| Date Mfgr Received | 2014-05-06 |
| Date Added to Maude | 2014-09-11 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAURA BOLL |
| Manufacturer Street | 102 EAST KEEFE AVE. |
| Manufacturer City | MILWAUKEE WI 53212 |
| Manufacturer Country | US |
| Manufacturer Postal | 53212 |
| Manufacturer Phone | 4147554806 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NI |
| Generic Name | BOUGIE |
| Product Code | FAT |
| Date Received | 2014-09-10 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOVATIONS |
| Manufacturer Address | MILWAUKEE WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2014-09-10 |