DR SCHOLLS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-12-04 for DR SCHOLLS manufactured by Bayer Healthcare Llc, Consumer Care.

Event Text Entries

[129246527] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2248903-2018-00007
• MDR Report Key: 8130395
• Report Source: CONSUMER,OTHER
• Date Received: 2018-12-04
• Date of Report: 2018-12-04
• Date Mfgr Received: 2018-11-30
• Date Added to Maude: 2018-12-04
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: K SHAW LAMBERSON
• Manufacturer Street: 100 BAYER BLVD.
• Manufacturer City: WHIPPANY NJ 07981
• Manufacturer Country: US
• Manufacturer Postal: 07981
• Manufacturer G1: BAYER HEALTHCARE LLC, CONSUMER CARE
• Manufacturer Street: 36 COLUMBIA RD.
• Manufacturer City: MORRISTOWN NJ 07960
• Manufacturer Country: US
• Manufacturer Postal Code: 07960
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DR SCHOLLS
• Generic Name: ORTHOSIS, CORRECTIVE SHOE
• Product Code: KNP
• Date Received: 2018-12-04
• Model Number: NA
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BAYER HEALTHCARE LLC, CONSUMER CARE
• Manufacturer Address: 36 COLUMBIA RD. MORRISTOWN NJ 07960 US 07960

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2018-12-04