Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems
Pain (1994); Injury (2348)
Event Type
Injury
Manufacturer Narrative
Based on the information provided by the complainant, details regarding a specific correlation between the unspecified surgisis product¿s performance and the alleged injury remain unknown.A root cause of the claim allegations is inconclusive due to the lack of details provided by the complainant.All other matters relating to this litigation are being handled by our attorney.A follow-up mdr will be filed if additional details are obtained.
Event Description
The patient was reportedly implanted with a boston scientific microvasive and an unspecified surgisis product on (b)(6) 2010, at (b)(6) medical center in (b)(6), by dr.(b)(6).The patient and her attorney have alleged that as a result of these products being implanted in the patient, the patient has experienced pain, injury, and has undergone medical treatment.