Model Number LCT, TP NPD 28G 100CT50/CASE LT BL |
Device Problems
Manufacturing, Packaging or Shipping Problem (2975); Material Twisted/Bent (2981)
|
Patient Problem
Pain (1994)
|
Event Date 04/02/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Internal report reference number: (b)(4).Lancets were not returned for evaluation - customer returned empty box/carton.Note: manufacturer contacted customer in a follow-up call on 12-apr-2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
|
|
Event Description
|
Consumer reported complaint for the trueplus 28g lancets.Wife is calling on behalf of the customer.Customer stated that he experienced pain after using the lancet, and when he looked in the lancet, it had two needles (double needle).Customer stated that one of the needles was bent.The package had not been open or damaged when received by the customer.At the time of the call the customer felt well and did not report any symptoms.No medical intervention related to the use of the product was reported.
|
|
Manufacturer Narrative
|
Sections with additional information as of 24-june-2021: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: :complaint was forwarded to supplier quality based on complaint's description for investigations.No product was returned to thi.Internal evaluation has been completed by the manufacturer and report attached into the case.No abnormalities observed with retain samples.Added most likely underlying root cause mlc-140: supplier manufacturing defect.
|
|
Search Alerts/Recalls
|