MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-02 for MAJ-1632 MOUTHPIECE (BOX 50 PCS) K10020960 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[53907788]
The device was not returned to olympus for evaluation. The root cause for the patient's outcome cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[53907789]
Olympus was informed that a patient underwent an unspecified procedure using the mouthpiece and experienced an allergic reaction. The physician reported he observed that the patient's lips were swollen and a rash appeared were the straps to the mouthpiece were located on the patient's face. The patient was administered benadryl and the reaction began to dissipate. The patient is reportedly doing well.
Patient Sequence No: 1, Text Type: D, B5
[58622160]
This supplemental report is being submitted to report additional information received from the original equipment manufacturer (oem). Oem indicated that "this is the first reported event of this nature since the device was placed on the market in 2011. During the development phase of the device was tested to confirm the biocompatibility to iso 10993. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2016-00713 |
| MDR Report Key | 5926849 |
| Date Received | 2016-09-02 |
| Date of Report | 2016-10-27 |
| Date of Event | 2016-08-17 |
| Date Mfgr Received | 2016-10-26 |
| Date Added to Maude | 2016-09-02 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-512 |
| 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 | 2016-09-02 |
| Model Number | K10020960 |
| Catalog Number | K10020960 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2016-09-02 |