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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIP RETRACTOR DBL END; M54 ORAL SURGERY

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INTEGRA LIP RETRACTOR DBL END; M54 ORAL SURGERY Back to Search Results
Catalog Number 017-31622
Device Problems Component Falling (1105); Degraded (1153)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Customer initially reports the product curls and material falls off.On (b)(6) 2014, customer reports coating on device is deteriorating and flaking off in the pt's mouth.No harm done.No further info available.
 
Manufacturer Narrative
The device involved in the reported incident has been received for eval.An investigation has been initiated based on the reported info.
 
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Brand Name
LIP RETRACTOR DBL END
Type of Device
M54 ORAL SURGERY
Manufacturer (Section D)
INTEGRA
york PA 17402
Manufacturer Contact
sandra lee
315 enterprise drive
6099366828
MDR Report Key4454519
MDR Text Key16178448
Report Number2523190-2014-00077
Device Sequence Number1
Product Code EKS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 12/29/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number017-31622
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/29/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/29/2014
Initial Date FDA Received01/21/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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