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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA YORK, PA INC. RUBBER DAM PUNCH M51 - GENERAL DENTISTRY

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INTEGRA YORK, PA INC. RUBBER DAM PUNCH M51 - GENERAL DENTISTRY Back to Search Results
Catalog Number 766A
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/23/2020
Event Type  malfunction  
Manufacturer Narrative
Attempts are being made to obtain additional information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A customer reported that the tip of the 766a rubber dam punch broke off in a patient's mouth during an unspecified dental procedure on (b)(6) 2020. They were able to retrieve it without causing harm to the patient. There was no known delay in surgery. Additional information has been requested.
 
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Brand NameRUBBER DAM PUNCH
Type of DeviceM51 - GENERAL DENTISTRY
Manufacturer (Section D)
INTEGRA YORK, PA INC.
589 davies drive
589 davies drive
york PA 17402
Manufacturer (Section G)
INTEGRA YORK, PA INC.
589 davies drive
york PA 17402
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 08540
6099362319
MDR Report Key10715798
MDR Text Key214589756
Report Number2523190-2020-00118
Device Sequence Number1
Product Code EJG
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number766A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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