FDA Adverse Event Other Summary report: N

INCA

MDR report key: 4340675 · Received December 9, 2014

Report

Report Number
1216677-2014-00019
Event Type
Other
Date Received
December 9, 2014
Date of Event
October 22, 2014
Report Date
October 29, 2014
Manufacturer
COOPERSURGICAL, INC.
Product Code
CAT
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). COOPERSURGICAL INC IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. A FINAL REPORT WILL BE FILED AFTER CUSTOMER FOLLOW UP AND INVESTIGATION IS COMPLETE.

Description of Event or Problem · 1

HOSPITAL REPORTED INCA PRONGS DISCONNECTING DURING USE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
792871 INCA CAT COOPERSURGICAL, INC. 44-2715 159915

Patients

Seq Age Sex Outcome Treatment
1 Other