inforMED
OtherGDM

COOPER SURGICAL

Received Sep 10, 2004

Report 1216677-2004-00013 · MDR key 5350308

Device

Generic name

Aspiration Needle

Product problems

  • Insufficient Device Problem Information

Patient

Not reported

  • No Information

Narrative

Additional Manufacturer Narrative

COOPER SURGICAL BECAME AWARE OF THE EVENT FROM A MEDWATCH FORM SENT FROM THE USER FACILITY. THE USER FACILITY DID NOT IDENTIFY THE DEVICE ON THE FORM. THIS FACILITY DOES NOT RETURN SUBJECT DEVICES. ATTEMPTS TO POSITIVELY IDENTIFY THE DEVICE HAVE FAILED THUS FAR. THE EFFORT TO IDENTIFY THE DEVICE CONTINUES AND F/U INFO WILL BE SUBMITTED IF OBTAINED. (B)(4).

Description of Event or Problem

(B)(4).