MAUDE Adverse Event Report: BAYER HEALTHCARE LLC, CONSUMER CARE DR SCHOLLS ATHLETIC SERIES RUNNING INSOLES MN; ORTHOSIS, CORRECTIVE SHOE LIMB ORTHOSIS

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

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of medical device site burn ('they literally burn my feet when running') in a patient who received dr scholls athletic series running insoles mn.On an unknown date, the patient started dr scholls athletic series running insoles mn.On an unknown date, the patient experienced medical device site burn (seriousness criterion medically significant).It was unknown whether any action was taken with dr scholls athletic series running insoles mn.At the time of the report, the medical device site burn outcome was unknown.The reporter considered medical device site burn to be related to dr scholls athletic series running insoles mn.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.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 ATHLETIC SERIES RUNNING INSOLES MN
• Type of Device: ORTHOSIS, CORRECTIVE SHOE LIMB ORTHOSIS
• 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. lamberson ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 8748156
• MDR Text Key: 149636563
• Report Number: 2248903-2019-00001
• Device Sequence Number: 1
• Product Code: KNP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 06/19/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other