UROVAC¿ BLADDER EVACUATOR
Received Sep 14, 2017
Report 3005099803-2017-02788 · MDR key 6865340
Device
Generic name
Evacuator, Bladder, Manually Operated
Manufacturer
Boston Scientific - Costa Rica (coyol)Model number
M0067301251Catalog number
730-125
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Injury
- Injury
Narrative
Additional Manufacturer Narrative
THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. IT WAS REPORTED THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROVAC BLADDER EVACUATOR WAS USED ON A PROCEDURE PERFORMED TWO AND HALF YEAR AGO. ACCORDING TO THE COMPLAINANT, THE PATIENT SUFFERED AN INJURY DUE TO A UROLOGY DEVICE USED IN A GYNECOLOGICAL PROCEDURE. HOWEVER, THE NATURE AND CAUSE OF THE INJURY IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.