MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-08 for OLYMPUS MAJ-1632 manufactured by Keymed (medical & Industrial Equipment) Limited.
[138231558]
From staff: patient had an emergent egd. A bite block was inserted by the scrub rn at the beginning of the procedure. At the end of the procedure, the crna removed the bite block and one of the patient's left bottom teeth fell out. The patient was missing other teeth along the bottom, a chest x-ray was ordered in pacu to make sure no other teeth had come out during the procedure and gone down into his lungs. No foreign body identified on x-ray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8403189 |
| MDR Report Key | 8403189 |
| Date Received | 2019-03-08 |
| Date of Report | 2019-02-26 |
| Date of Event | 2019-02-06 |
| Report Date | 2019-02-26 |
| Date Reported to FDA | 2019-02-26 |
| Date Reported to Mfgr | 2019-03-08 |
| Date Added to Maude | 2019-03-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | OLYMPUS |
| Generic Name | ENDOSCOPIC BITE BLOCK |
| Product Code | MNK |
| Date Received | 2019-03-08 |
| Model Number | MAJ-1632 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITED |
| Manufacturer Address | OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY CENTER VALLEY PA 180340610 US 180340610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-08 |