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

Model Number	310CR
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information available, no patient injury occurred.This event is being reported based on its similarity to a previous submission.A recall associated with this lot had already been initiated prior to the receipt of this complaint.
Event or Problem Description
Circlamp removed foreskin without the use of scalpel.

• Brand Name: CENTURION CIRCLAMP
• Common Device Name: CIRCUMCISION CLAMP
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; 100 centurion way; williamston, mi
• MDR Report Key: 9842270
• Report Number: 1824619-2020-00003
• Device Sequence Number: 19540532
• Product Code: HFX
• UDI-Device Identifier: 00653160197471
• UDI-Public: (01)00653160197471(10)2019061801(17)240331
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K890897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2024
• Device Model Number: 310CR
• Device Lot Number: 2019061801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 4 DA
• Patient Weight: 3