H3: product is not available for return.Therefore, this report is based solely on the information provided by the customer.Complaint was reported to the manufacturer by mcarthur medical, a canadian importer for grip-lok devices.Additional information related to the incident was requested.The importer reached out to their customer service department to contact the customer, since this product has been provided as a sub ¿ ie.They are new users.Unknown if training was received when the sub was offered.As of march 7, 2024, no new information has been received related to this complaint.At this time, there is no evidence that a manufacturing error contributed to the reported failure.Based on historical complaint data and information currently available, likely root cause is due to new users and device training issues.(b)(4).All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file (b)(4).
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