MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY ADULT BITE BLOCK-LATEX FREE; SCOPE SAVER DISPOSABLE BITEBLO

Model Number	000429
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation by the user facility, therefore; the reported failure could not be verified and a root cause cannot be conclusively determined.A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified at the time of manufacture.A two-year review of complaint history revealed one other similar complaint for this product family and failure mode.In that same timeframe, (b)(4) units of this product family have been sold worldwide, making the rate of occurrence of this failure (b)(4)percent, should all complaints be confirmed.No failure mode was reported for this device by the user facility, therefore; a risk analysis was unable to be conducted due to lack of a failure mode of the device.The instructions for use advises the user of the following.- removal of dentures or partial dental plates is recommended per physician's directions.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The user facility reported that an upper endoscopy procedure with the 000429 bite block resulted in damage to the patient's dentition.The four teeth in the lower frontal region were noticed to be dislodged.There was no procedural delay associated with this incident.Upon gathering additional information, it was noted that the patient had the dental history of missing upper molars bilaterally and poor dentition.The patient was discharged home and required additional work on affected teeth due to this event.This report is raised on the basis of a reported patient injury.

• Brand Name: ADULT BITE BLOCK-LATEX FREE
• Common Device Name: SCOPE SAVER DISPOSABLE BITEBLO
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua CP 11 36; MX CP 1136
• MDR Report Key: 7337388
• Report Number: 3007305485-2018-00055
• Device Sequence Number: 19141214
• Product Code: KTI
• UDI-Device Identifier: 20653405050282
• UDI-Public: (01)20653405050282(17)200116(10)201801164
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K833491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/16/2020
• Device Model Number: 000429
• Device Catalogue Number: 000429
• Device Lot Number: 201801164
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Weight: 61