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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GOMCO CIRCUMCISION CLAMP; CLAMP, CIRCUMCISION
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GOMCO CIRCUMCISION CLAMP; CLAMP, CIRCUMCISION Back to Search Results
Device Problems Mechanics Altered (2984); Separation Problem (4043)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/27/2022
Event Type  malfunction  
Event Description
Infant was getting circumcision and gomco would not rotate off.
 
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Brand Name
GOMCO CIRCUMCISION CLAMP
Type of Device
CLAMP, CIRCUMCISION
MDR Report Key15969628
MDR Text Key305383799
Report Number15969628
Device Sequence Number1
Product Code HFX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/05/2022
Event Location Hospital
Date Report to Manufacturer12/12/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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