TRIMO SAN

Additional Manufacturer Narrative

COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT WILL NOT BE RETURNED BY THE PATIENT FOR EVALUATION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE FILED. REFERENCE E-COMPLAINT (B)(4) *** FOLLOW UP 02/07/2017 *** INVESTIGATION: INITIATED MANUFACTURER'S INVESTIGATION. X-NO SAMPLE RETURNED. X-REVIEW DHR. INSPECT RETURNED SAMPLES. 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. A REVIEW OF THE DHR'S ((B)(4)) SHOW NO ABNORMALITIES. 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 SHOULD THE SAMPLES BE RETURNED, THIS COMPLAINT WILL BE REOPENED AND RE-EVALUATED. THIS COMPLAINT WILL BE ENTERED INTO THE COOPER SURGICAL CONTINUOUS IMPROVEMENT PLAN (CIP).

Description of Event or Problem

REFERENCE E-COMPLAINT (B)(4). "CALLER STATED THAT SHE IS A USER OF THE DEVICE AND KNEW IMMEDIATELY THAT HER APPLICATOR HAS A SHARP OPENING, SAID SHE RAN HER HANG ACROSS THE OPENING AND COULD FEEL ITS SHARPNESS. CUSTOMER STATED SHE USED IT ANYWAY BUT TRIED TO USE IT IN A WAY THAT THE COULD AVOID THE SHARP OPENING SCRAPPING AGAINST HER SKIN BUT WAS UNFORTUNATE. SHE IS A BIT SORE BORDER LINE ACHING FEATHER LINE BLOOD. CALLER STATES WHEN WIPING A BIT OF DARK TINT CAN BE SEEN CALLER ALSO STATED THAT SHE WILL WATCH ACHING FOR A WEEK AND IF SYMPTOMS ARE STILL PRESENT SHE WILL MAKE AN APPOINTMENT TO SEE OBGYN"

Additional Manufacturer Narrative

COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT WILL NOT BE RETURNED BY THE PATIENT FOR EVALUATION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE FILED. (B)(4). PRODUCT WILL NOT BE RETURNED.

Description of Event or Problem

(B)(4). "CALLER STATED THAT SHE IS A USER OF THE DEVICE AND KNEW IMMEDIATELY THAT HER APPLICATOR HAS A SHARP OPENING, SAID SHE RAN HER HAND ACROSS THE OPENING AND COULD FEEL ITS SHARPNESS. CUSTOMER STATED SHE USED IT ANYWAY BUT TRIED TO USE IT IN A WAY THAT THE COULD AVOID THE SHARP OPENING SCRAPPING AGAINST HER SKIN BUT WAS UNFORTUNATE. SHE IS A BIT SORE BORDER LINE ACHING FEATHER LINE BLOOD. CALLER STATES WHEN WIPING A BIT OF DARK TINT CAN BE SEEN CALLER ALSO STATED THAT SHE WILL WATCH ACHING FOR A WEEK AND IF SYMPTOMS ARE STILL PRESENT SHE WILL MAKE AN APPOINTMENT TO SEE OBGYN"