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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CENTURION CIRCLAMP; CIRCUMCISION CLAMP

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CENTURION MEDICAL PRODUCTS CENTURION CIRCLAMP; CIRCUMCISION CLAMP Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Injury (2348)
Event Type  malfunction  
Manufacturer Narrative
Based on the information available, no patient injury occurred.This event is being reported based on its similarity to a previous submission.Additionally, it should be noted that a recall associated with this issue had already been initiated prior to the receipt of this complaint.However, as a lot number was not reported and no sample was available, we are unable to determine if the device used in this report is included in the recalled lots.
 
Event Description
Circlamp removed foreskin without the use of scalpel.
 
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Brand Name
CENTURION CIRCLAMP
Type of Device
CIRCUMCISION CLAMP
Manufacturer (Section D)
CENTURION MEDICAL PRODUCTS
100 centurion way
williamston, mi
Manufacturer (Section G)
CENTURION MEDICAL PRODUCTS
301 catrell dr
howell, mi
Manufacturer Contact
karen kowalczyk
100 centurion way
williamston, mi 
5451122
MDR Report Key9842269
MDR Text Key190937180
Report Number1824619-2020-00002
Device Sequence Number1
Product Code HFX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K890897
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Risk Manager
Remedial Action Recall
Type of Report Initial
Report Date 03/17/2020
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? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/20/2020
Initial Date FDA Received03/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age4 DA
Patient Weight3
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