MAUDE Adverse Event Report: RANEY SCALP CLIP DISPOSE; CLIPS, SCALP

Lot Number BH606

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

Patient Problem No Information (3190)

Event Date 11/11/2015

Event Type  malfunction  

Manufacturer Narrative

Gtin: unknown.Upon completion of the investigation, a follow up report will be filed.

Event Description

A foreign matter (metal fragment) was found in the package of the device during pre-use inspection.There were no adverse consequences associated with this event.

• Brand Name: RANEY SCALP CLIP DISPOSE
• Type of Device: CLIPS, SCALP
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5265432
• MDR Text Key: 32665104
• Report Number: 1226348-2015-10728
• Device Sequence Number: 1
• Product Code: HBO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: BH606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1