Model Number 1960-50-250 |
Device Problems
No Apparent Adverse Event (3189); Inaccurate Information (4051)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/24/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Event description: an ar-medica client contacted us complaining that the country of origin does not match between the shipping invoice and the box label.At the moment, customs has identified 7 codes in the depuy business with such a discrepancy.
|
|
Manufacturer Narrative
|
Product complaint (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.H6.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Upon review of the complaint this was reported in error.There was not a product malfunction or patient harm related to the reported issue.No further information will be provided related to the event.If additional information is received, the complaint will be reviewed and the reportability decision will be reassessed at that time.
|
|
Search Alerts/Recalls
|