MAUDE Adverse Event Report: BAYER HEALTHCARE LLC, CONSUMER CARE DR SCHOLLS CUSTOM FIT ORTHOTIC INSERTS 110; ORTHOSIS, CORRECTIVE SHOE LIMB ORTHOSIS

Lot Number CS410

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/02/2019

Event Type  Injury  

Event Description

This spontaneous case was reported by a family member and describes the occurrence of foot fracture ('my daughter broke her toe /it is her fourth metatarsal on her foot') in a female patient who received dr scholls custom fit orthotic inserts 110.On an unknown date, the patient started dr.Scholls custom fit orthotic inserts 110.On an unknown date, the patient experienced foot fracture (seriousness criterion medically significant).It was unknown whether any action was taken with dr scholls custom fit orthotic inserts 110.At the time of the report, the foot fracture outcome was unknown.The reporter considered foot fracture to be related to dr scholls custom fit orthotic inserts 110.The reporter commented: my daughter broke her toe; i think it was due to the insert that she was wearing some dr.Scholls we purchased those at the kiosk machine you stand on tells you what so you need for your shoes insert and her toes the way this in-service made it so hung over the insert and she stepped down she broke her toe.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.

Manufacturer Narrative

This spontaneous case was reported by a family member and describes the occurrence of foot fracture ('my daughter broke her toe /it is her fourth metatarsal on her foot') in a female patient who received dr scholls custom fit orthotic inserts 110 (batch no.Cs410).In (b)(6) 2019, the patient started dr scholls custom fit orthotic inserts 110 at an unspecified dose and frequency.On (b)(6) 2019, the patient experienced foot fracture (seriousness criteria medically significant and intervention required) with pain in extremity.The patient was treated with ibuprofen.It was unknown whether any action was taken with dr scholls custom fit orthotic inserts 110.At the time of the report, the foot fracture outcome was unknown.The reporter considered foot fracture to be related to dr scholls custom fit orthotic inserts 110.The reporter commented: my daughter broke her toe; i think it was due to the insert that she was wearing some dr.Scholl s we purchased those at the kiosk machine you stand on tells you what so you need for your shoes insert and her toes the way this in-service made it so hung over the insert and she stepped down she broke her toe.She fractured her 4th metatarsal and is in a boot cast.She had pain but is seems to be easing up now and she is back in school.She has mri done and the doctor gave her ibuprofen for the pain.Most recent follow-up information incorporated above includes: on 20-aug-2019: "pain in extremity" added as symptom of toe fracture, reporter added:(other health professional), reporter information updated, suspect product onset date added, event start date was added.Added lot number.We received a lot number/returned sample in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

• Brand Name: DR SCHOLLS CUSTOM FIT ORTHOTIC INSERTS 110
• Type of Device: ORTHOSIS, CORRECTIVE SHOE LIMB ORTHOSIS
• Manufacturer (Section D): BAYER HEALTHCARE LLC, CONSUMER CARE; 36 columbia rd.; morristown NJ 07960
• MDR Report Key: 8905463
• MDR Text Key: 155030130
• Report Number: 2248903-2019-00002
• 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,Followup
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: CS410
• Initial Date Manufacturer Received: 08/10/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 08/20/2019
• Supplement Dates FDA Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention