| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | WASHED OIL, GLASS, 100ML | WASHED OIL, GLASS, 100ML | COOPERSURGICAL, INC. | MQL | ART-4009W | ART-4009W | NI | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-04-28 | 0 | 1. O |
Patient 1
THE ART-4009W INVOLVED IN THE COMPLAINT WILL NOT BE RETURNED. COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE FILED. REFERENCE E-COMPLAINT: (B)(4). DEVICE NOT WILL NOT BE RETURNED.
Patient 1
"EMBRYOLOGIST CUT HERSELF ON BROKEN BOTTLE." REF E-COMPLAINT (B)(4).
Patient 1
(B)(4). INVESTIGATION: INITIATED MANUFACTURER'S INVESTIGATION. X-NO SAMPLE RETURNED. X-REVIEW DHR. INSPECT RETURNED SAMPLES. X-INSPECT STOCK PRODUCT. ANALYSIS AND FINDINGS: INVESTIGATION IS COMPLETE. DHR REVIEW SHOW THE SUBJECT DEVICE MET ALL APPROVED RELEASE SPECIFICATION AT THE TIME OF MANUFACTURE BEFORE IT WAS RELEASED. THERE WERE NO RELATED NONCONFORMANCE NOTED IN THE PRODUCTION RECORDS. COMPLAINT HISTORY REVIEW DID NOT SHOW ANY SIMILAR COMPLAINTS. THERE HAVE NOT BEEN ANY MANUFACTURING ISSUES IN THE LAST 2 YEARS. THE MANUFACTURING OF THE SAGE? PRODUCT HAVE SINCE BEEN MOVED TO DENMARK. THERE HAVE NOT BEEN ANY RELATED SPECIFICATION CHANGES DURING REVIEW OF THE PRODUCT PACKING COMPONENTS. HISTORICAL DISTRIBUTION TO THE FACILITY SHOWS THE CUSTOMER HAD ORDERED SIMILAR PRODUCTS IN THE PAST WITH NO ISSUES. HISTORICAL REVIEW SHOW THE SUBJECT LOTS HAVE BEEN SHIPPED TO BOTH DOMESTIC AND INTERNATIONAL CUSTOMERS WITH NO PROBLEMS. THE PRODUCTS ARE SHIPPED WITH AN APPROVED PACKAGING BOXES WITH DIVIDERS SEPARATING THE BOTTLES. THE SUBJECT PRODUCT WAS SHIPPED ON APRIL 18 2016 AND WAS DELIVERED ON APRIL 20TH 2016 TO NEWLIFE IVF INC ((B)(4)). THE ALLEGED INCIDENT OCCURRED SHORTLY AFTER RECEIVING THE PRODUCT. ON APRIL 21ST 2016 CSI'S PRODUCT SURVEILLANCE CONTACTED NEWLIFE IVF INC TO GATHER ADDITIONAL INFORMATION SURROUNDING THE REPORTED COMPLAINT CONDITION. THE FOLLOW UP WAS THROUGH DIRECT PHONE COMMUNICATION AND FOLLOWED A STANDARDIZED QUESTIONNAIRE USED FOR ALL COMPLAINTS. THE CUSTOMER INDICATED A TOPICAL ANTIBIOTIC WAS APPLIED TO THE CUT. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION PERFORMED. COOPERSURGICAL FOLLOWED UP AGAIN ON APRIL 29TH 2016 VIA A PHONE CALL TO THE FACILITY AND THE PATIENT IS DOING WELL. THE CUSTOMER HOWEVER INDICATED THEY WANTED THE ENTIRE ORDER REPLACED WITH A NEW ONE. COOPERSURGICAL HONORED THE REQUEST BY SENDING THE CUSTOMER REPLACEMENT PRODUCTS UNDER REPLACEMENT ORDER NUMBER (B)(4). THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS DISCARDED BY THE CUSTOMER AND NOT AVAILABLE FOR EVALUATION. CORRECTIVE ACTIONS: CORRECTION AND/OR CORRECTIVE ACTION - NONE. CORRECTIVE ACTION LEVEL 3: NONE. REASON:TREND AND MONITOR TO CIP. WAS THE COMPLAINT CONFIRMED? NO. REVIEW AND CLOSURE: CAPA REQUIRED? RECOMMENDED CONTINUOUS IMPROVEMENT PROGRAM (CIP). COMPLAINT CLOSURE LETTER REQUIRED? NCMR ISSUED? OTHER REGULATORY ACTION NEEDED: PREVENTATIVE ACTION ACTIVITY. REVIEWED. TREND AND MONITOR TO CIP. DEVICE NOT WILL NOT BE RETURNED.
Patient 1
"EMBRYOLOGIST CUT HERSELF ON BROKEN BOTTLE." (B)(4).