MAUDE Adverse Event Report: CAREFUSION, INC MOGEN CIRCUMCISION CLAMP; CLAMP, CIRCUMCISION

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 12/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) on 19dec2017 bd became aware of this complaint.This record is involved with a legal matter and customer is not to be contacted.Device not yet evaluated, if the device is evaluated a follow up will be sent.

Event Description

Notice received by legal department states: infant child suffered a partial amputation of his penis during circumcision on (b)(6) 2017.To date there is no further identifying information or serial number for the clamp.No further information available.

• Brand Name: MOGEN CIRCUMCISION CLAMP
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061
• MDR Report Key: 7196292
• MDR Text Key: 97426652
• Report Number: 1423507-2017-00202
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2018

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?: No
• Device Operator: Physician
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability