MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-08-23 for MAJ-1632 MOUTHPIECE (BOX 50 PCS) K10020960 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[83366337]
Maj-1632 is a single-use endoscope mouthpiece. The instructions for use advise: - 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. Keymed has requested more details about the event.
Patient Sequence No: 1, Text Type: N, H10
[83366338]
Keymed (medical and industrial equipment) ltd has been made aware of an event in (b)(6) where two tooth tips were broken during bronchoscopy (flexible bronchoscope) while using maj-1632 mouthpiece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2017-00004 |
| MDR Report Key | 6812674 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-23 |
| Date of Report | 2017-11-29 |
| Date Mfgr Received | 2017-11-29 |
| Date Added to Maude | 2017-08-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR PETER MORCOS |
| Manufacturer Street | KEYMED HOUSE, STOCK ROAD |
| Manufacturer City | SOUTHEND ON SEA, ESSEX |
| Manufacturer Country | US |
| Manufacturer Phone | 0441702616 |
| 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 | 2017-08-23 |
| Model Number | K10020960 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-23 |