Catalog Number K11-MPT2006C |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/24/2021 |
Event Type
malfunction
|
Event Description
|
The account alleges that during inspection a breach in the packaging was found.No patient consequence to report.
|
|
Manufacturer Narrative
|
The suspect device has been returned for evaluation.Visual inspection confirmed there was damage to the clear film.The complaint is confirmed.The root cause is attributed to the manufacturing process.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.Corrective actions are in process.
|
|
Search Alerts/Recalls
|