MAUDE Adverse Event Report: BAYER HEALTHCARE LLC, CONSUMER CARE DR SCHOLLS; ORTHOSIS, CORRECTIVE SHOE

Device Problem Insufficient Information (3190)

Patient Problem Joint Disorder (2373)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of limb discomfort ("serious problems with my feet"), musculoskeletal discomfort ("serious problems with my ankles") and arthropathy ("serious problems with my knees") in a patient who received dr scholls custom fit orthotic inserts 330 (batch no.Unk).Other product or product use issues identified: device ineffective "did not notice any difference." in 2018.In 2018, the patient started dr scholls custom fit orthotic inserts 330 at an unspecified dose and frequency.On an unknown date, the patient experienced limb discomfort (seriousness criterion medically significant), musculoskeletal discomfort (seriousness criterion medically significant) and arthropathy (seriousness criterion medically significant).It was unknown whether any action was taken with dr scholls custom fit orthotic inserts 330.At the time of the report, the limb discomfort, musculoskeletal discomfort and arthropathy outcome was unknown.The reporter provided no causality assessment for arthropathy, limb discomfort and musculoskeletal discomfort with dr scholls custom fit orthotic inserts 330.The reporter commented: he has, in the past month, been hospitalized for a week, seen several doctors, orthopedic, and podiatry, had cat scans, mri's, and they are still trying to determine what the problems are.Unfortunately, my problems are much bigger now.No lot number or device sample was received in this case.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

• Brand Name: DR SCHOLLS
• Type of Device: ORTHOSIS, CORRECTIVE SHOE
• Manufacturer (Section D): BAYER HEALTHCARE LLC, CONSUMER CARE; 36 columbia rd.; morristown NJ 07960
• Manufacturer (Section G): BAYER HEALTHCARE LLC, CONSUMER CARE; 36 columbia rd.; morristown NJ 07960
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd.; whippany, NJ 07981
• MDR Report Key: 8130395
• MDR Text Key: 129246527
• Report Number: 2248903-2018-00007
• Device Sequence Number: 1
• Product Code: KNP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 11/30/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other