(b)(6).Based on the available information, this event is deemed to be a reportable malfunction. additional information was requested.Should additional information become available, a follow-up report will be submitted. fda registration number.Reporting site: 1049092.Manufacturing site: 1049092.
|
Correction ¿ retraction of udi number, and update of lot number.This complaint has been evaluated.A review of the last three (3) product monitoring review's for trends indicated no trends for this issue on this product.The historical complaint data from (b)(6) 2015 to (b)(6) 2017 was reviewed as it relates to reports for product (b)(4).A total of one (1) complaint, including this one, was reported.This issue will be monitored through the post market product monitoring review process.No additional event detail information has been provided to date.Should additional information become available, a follow up report will be submitted.(b)(4).
|