MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-21 for MAJ-1632 MOUTHPIECE (BOX 50 PCS) K10020960 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[145732713]
The device will not be returned as the user facility discarded the device following the procedure. Therefore, the cause of the reported event cannot be confirmed. As part of our investigation, follow up with the user facility to obtain additional information regarding the reported event was performed. On may 15, 2019, the risk manager at the user facility further reported there was nothing wrong with the device itself that caused the patient's broken tooth. The patient did not have any other dental or anatomical features that affected the positioning of the mouthpiece. There was no unusual phenomena such as the patient moving around. There was no treatment or intervention procedure required as a result. There was no unexpected bleeding to the patient. The procedure was completed using the same device. The patient was reported to be in good condition. In addition, no other equipment was replaced. The device was inspected prior to procedure with no anomalies observed. Scope used was an unknown gastroscope. The device was stored in a drawer with other bite blocks; no exposure to heat/sunlight. A review of the device history records could not be conducted as there was no lot number reported. The prevent patient injury, the device instruction for use manual cautions, "to prevent the patient from accidentally loosening a dental prosthesis, make sure that the patient removes it before the examination. " it also cautions, "monitor patient during use to ensure no injury is caused by the mouthpiece in the oral cavity. "
Patient Sequence No: 1, Text Type: N, H10
[145732714]
The manufacturer received a medwatch report (b)(4) on april 23, 2019, which states,? From staff: patient had documented bonded front tooth prior to procedure on the anesthesia record. After the procedure in , the patient informed recovery nurse that the patient? S tooth was broken. The anesthetist and doctor examined and spoke to the patient. The charge nurse and department head were made aware. The patient stated that her tooth was repaired several years ago. In (b)(6) 2019, patient had a bite block inserted before the esophagogastroduodenoscopy, the scope was inserted through the bite block and the bite block taken out after the procedure. Patient was taken to post op.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00857 |
| MDR Report Key | 8629752 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-21 |
| Date of Report | 2019-05-21 |
| Date Mfgr Received | 2019-04-23 |
| Date Added to Maude | 2019-05-21 |
| 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 | 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 | 2019-05-21 |
| 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 | 2019-05-21 |