MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-11-19 for HURST ESOPHAGEAL BOUGIE DILATOR #34FR NA manufactured by V. Mueller.
[2953230]
Pt had elective bariatric procedure in operating room. Esophageal dilator leaked memory into pt and operating room environment, thus contaminating pt, staff and room. Actions were performed to prevent harm and reduce exposure to staff, pt, and physicians.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2858925 |
| MDR Report Key | 2858925 |
| Report Source | 99 |
| Date Received | 2012-11-19 |
| Date of Report | 2012-11-12 |
| Date of Event | 2012-11-01 |
| Date Facility Aware | 2012-11-01 |
| Report Date | 2012-11-12 |
| Date Added to Maude | 2012-12-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HURST ESOPHAGEAL BOUGIE DILATOR |
| Generic Name | BOUGIE DILATOR-MERCURY FILLED |
| Product Code | FAT |
| Date Received | 2012-11-19 |
| Model Number | #34FR |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | V. MUELLER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-11-19 |