MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2019-04-11 for MAJ-1632 MOUTHPIECE (BOX 50 PCS) K10020960 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[141724345]
The device was not returned to olympus for evaluation. Olympus followed up with the user facility regarding the reported event and was informed by the facility? S endoscopy manager that the patient had a pre-existing dental issue as the affect teeth had been bonded in place. The cause of the reported event cannot be conclusively determined. The instructions for use advise users? When placing the mouthpiece into the patient's mouth, take care to avoid placing fingers between the mouthpiece and the patient's teeth. Before using the mouthpiece, check the condition of the patient's teeth. In case of any irregularity, take additional care to prevent any further trauma. Care should be taken when removing mouthpiece to prevent injury in the oral cavity.?
Patient Sequence No: 1, Text Type: N, H10
[141724346]
Olympus received a medwatch report that states a patient's left bottom teeth fell out when the certified registered nurse anesthetist removed the mouthpiece, after an emergency esophagogastroduodenoscopy (egd) procedure. The facility? S scrub rn had inserted the mouthpiece at the beginning of the procedure without issue. 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 | 2951238-2019-00729 |
| MDR Report Key | 8506735 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2019-04-11 |
| Date of Report | 2019-04-11 |
| Date Mfgr Received | 2019-03-13 |
| Date Added to Maude | 2019-04-11 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAJ-1632 MOUTHPIECE (BOX 50 PCS) |
| Generic Name | ENDOSCOPIC BITE BLOCK |
| Product Code | MNK |
| Date Received | 2019-04-11 |
| Model Number | K10020960 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. |
| Manufacturer Address | KEYMED HOUSE, STOCK ROAD SOUTHEND-ON-SEA, ESSEX SS2 5QH UK SS2 5QH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-11 |