MAUDE Adverse Event Report: COOPERVISION LENS CARE LTD. TEST

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2021

Event Type  Injury  

Manufacturer Narrative

This is a test submission for reissuance of signature certificate.

Event Description

This is a test submission for reissuance of signature certificate.

• Brand Name: TEST
• Type of Device: TEST
• Manufacturer (Section D): COOPERVISION LENS CARE LTD.; mace industrial estate; ashford, kent TN24 8EP; UK TN24 8EP
• Manufacturer (Section G): COOPERVISION LENS CARE LTD.; mace industrial estate; ashford, kent TN24 8EP; UK TN24 8EP
• Manufacturer Contact: melissa torpey ; 5870 stoneridge drive; suite 1; pleasanton, CA 94588 ; 5857569874
• MDR Report Key: 11541686
• MDR Text Key: 241427662
• Report Number: 9615939-2021-00001
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other