JEL-JECTOR,APPLICATOR

Additional Manufacturer Narrative

REFERENCE E-COMPLAINT (B)(4). THE COMPLAINT CONDITION REPORTED IS CURRENTLY BEING INVESTIGATED. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORTED WILL BE FILED.

Description of Event or Problem

PER FAX REPORT -CUSTOMER STATED END OF APPLICATOR SEEM TO SHARP AND HURTS INSIDE OF VAGINA CAUSING SLIGHT BLEEDING. REFERENCE E-COMPLAINT (B)(4).

Additional Manufacturer Narrative

REFERENCE E-COMPLAINT-(B)(4). INVESTIGATION: X-NO SAMPLE RETURNED AND X-INSPECT STOCK PRODUCT. ANALYSIS AND FINDINGS: AN EVALUATION OF THE COMPLAINANT SAMPLES COULD NOT BE CONDUCTED SINCE THEY WILL NOT BE RETURNED. THE APPLICATOR ASSEMBLY IS MADE UP OF THREE COMPONENT PARTS (THE BULB, THE FLYER AND THE TUBE) PURCHASED FROM AND ASSEMBLED BY A SUPPLIER. A REVIEW OF TWO YEAR COMPLAINT HISTORY SHOWS NO COMPLAINTS FOR THIS ISSUE. THE COMPLAINANT DID NOT DISCLOSE A LOT NUMBER. A REVIEW OF COOPERSURGICAL INCOMING INSPECTION RECORDS SHOWS NO REJECTIONS FOR THIS ISSUE. THE TUBE IS MOLDED BY A SUPPLIER AND HAS 8 CAVITIES. A SAMPLE OF ALL 8 CAVITIES IN STOCK INVENTORY FOUND ALL THE PARTS MET QUALITY REQUIREMENTS AND WERE NOT SHARP AT THE DISTAL END. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. CORRECTION AND/OR CORRECTIVE ACTION: NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. WILL CONTINUE TO MONITOR FOR TRENDING. SHOULD THE SAMPLES BE RETURNED, THIS COMPLAINT WILL BE REOPENED AND RE-EVALUATED. WAS THE COMPLAINT CONFIRMED? NO. PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

Description of Event or Problem

PER FAX REPORT -CUSTOMER STATED END OF APPLICATOR SEEM TO SHARP AND HURTS INSIDE OF VAGINA CAUSING SLIGHT BLEEDING. REFERENCE E-COMPLAINT-(B)(4).