BITE BLOCK - MAXI *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-09-20 for BITE BLOCK - MAXI * manufactured by Us Endoscopy.

Event Text Entries

[1431513] Patient undergoing an esophagogastroduodenoscopy (egd). During the procedrue a bite block was placed. When patient woke up in recovery it was noted that she had a 1mm cut on the inside right side of her lip. Bite block inspected. No sharp edges noted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1845177
MDR Report Key1845177
Date Received2010-09-20
Date of Report2010-07-06
Date of Event2010-05-25
Report Date2010-07-06
Date Reported to FDA2010-09-20
Date Added to Maude2010-09-27
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameBITE BLOCK - MAXI
Generic NameBITE BLOCK
Product CodeJXL
Date Received2010-09-20
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device Sequence No1
Device Event Key0
ManufacturerUS ENDOSCOPY
Manufacturer Address5976 HEISLEY RD. MENTOR OH 44060 US 44060


Patients

Patient NumberTreatmentOutcomeDate
10 2010-09-20

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