MAUDE Adverse Event Report: MEDLINE CLAMP, CIRCUMCISION; CIRCUMCISION CLAMP

Catalog Number SSI-0034

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2018

Event Type  malfunction  

Event Description

It was reported that the circumcision clamp was noted to have metal flakes on it when open for use.Was not used on pt.Cardinal cat #ssi-0034, lot #804822.

• Brand Name: CLAMP, CIRCUMCISION
• Type of Device: CIRCUMCISION CLAMP
• Manufacturer (Section D): MEDLINE ; one medline place; mundelein IL 60060
• MDR Report Key: 7299667
• MDR Text Key: 101242882
• Report Number: MW5075543
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SSI-0034
• Device Lot Number: 804822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1