Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Edema (1820); Post Operative Wound Infection (2446)
|
Event Date 11/14/2014 |
Event Type
Injury
|
Event Description
|
Device #2 of 4.Reference mfr.Report:1627487-2014-26988, reference mfr.Report:1627487-2014-26990, reference mfr.Report:1627487-2014-26991.
|
|
Manufacturer Narrative
|
Udi (di): (b)(4).Evaluation: method: the device history and sterilization records were reviewed.Results: the device history and sterilization records reviewed were found to meet specifications and no anomalies related to this event were found.Conclusion: the cause of the reported complaint could not be determined from the review of the dhr and sterilization records.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
|
|
Event Description
|
Device #2 of 4.Reference mfr.Report: 1627487-2014-26988, reference mfr.Report: 1627487-2014-26990, reference mfr.Report: 1627487-2014-26991.
|
|
Manufacturer Narrative
|
Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
|
|
Search Alerts/Recalls
|