MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-09 for DISPOSABLE LIGHTED BOUGIE TIP 40 manufactured by Medovations / Diversatek Healthcare Inc..
[183133501]
The tip of a lighted bougie was retained in a pt's esophagus following removal of a lighted bougie. The lighted bougie was used during a laparoscopic nissen procedure and the separation of the tip was not recognized. On the morning following surgery, pt complained of nausea, vomiting and a pain score of 12/10. Foreign object identified in the posterior oral pharynx and removed at bedside with forceps. Foreign object identified as the disposable tip of a lighted bougie. Permanent harm was not assessed. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093628 |
| MDR Report Key | 9810761 |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-01-07 |
| Date Added to Maude | 2020-03-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE LIGHTED BOUGIE TIP 40 |
| Generic Name | BOUGIE, ESOPHAGEAL, AND GASTROINTESTINAL, GASTRO-UROLOGY |
| Product Code | FAT |
| Date Received | 2020-03-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOVATIONS / DIVERSATEK HEALTHCARE INC. |
| Manufacturer Address | MILWAUKEE WI 43212 US 43212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-09 |