MAUDE Adverse Event Report: COOPERSURGICAL, INC. CANNULA CURETTE 8MM LONG

Model Number MX508

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/20/2014

Event Type  Other  

Event Description

Hospital reported excessive bleeding occurred during the procedure.

Manufacturer Narrative

Coopersurgical inc is currently investigating the stated complaint.The device involved in the complaint has not been retuned by the customer for evaluation.Once all information is received from the customer and the investigation has been completed a follow-up report will be filed.(b)(4).

• Brand Name: CANNULA CURETTE 8MM LONG
• Type of Device: CANNULA CURETTE
• Manufacturer (Section D): COOPERSURGICAL, INC.; trumbull CT
• Manufacturer Contact: nana banafo ; 75 corp dr; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 3705618
• MDR Text Key: 15118240
• Report Number: 1216677-2014-00004
• Device Sequence Number: 1
• Product Code: HFC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: MX508
• Device Lot Number: 144853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2014
• Date Device Manufactured: 08/01/2013
• 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