MAUDE Adverse Event Report: DONGGUAN YUN CHANG PLASTIC CO., LTD. DR. SCHOLL'S PAIN RELIEF ORTHOTIC BALL OF FOOT PAIN

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Sleep Dysfunction (2517); Limb Fracture (4518)

Event Date 01/25/2022

Event Type  Injury  

Manufacturer Narrative

The device was not returned.Subsequently no investigation for the device was not possible.

Event Description

On 15-feb-2022, a spontaneous report from the united states was received from a consumer via telephone regarding a (b)(6) female consumer who used dr.Scholl's ball of foot pain (lot number and expiration date not provided).Medical history included an allergy to latex and pain in the ball of her foot since (b)(6) 2021.The consumer was noted to be "very fit and walks an hour each day on a flat surface with podiatrist recommended athletic shoes." concomitant products included an unspecified multivitamin.On an unspecified date in (b)(6) 2021, the consumer started using the dr.Scholl's ball of foot pain which she inserted in her left shoe for pain in the ball of her left foot.She did not use an insert in her right shoe.On an unspecified date in (b)(6) 2021, after two weeks of using the dr.Scholl's ball of foot pain, she developed pain from walking on the ball of her foot.She had never had any foot pain in the past.She was walking on a paved path with good athletic shoe which were designed by podiatrists.She developed pain at the top of her foot.Approximately after the 3rd week of (b)(6) 2022, while she was walking the pain became excruciating and she had to stop walking.Subsequently, she took the insert out and her friend helped her get home.On an unspecified date around the 3rd week of (b)(6) 2022, she had a podiatry appointment.She showed her doctor the insert.The podiatrist examined her foot and took x-rays.She was told that she had broken her 3rd metatarsal bone right at the end point where the insert had arched her foot up.The podiatrist did not say that the insert had anything to do with the fracture, but she felt it did.She thought that using the insert broke her bone as her foot was forced into an abnormal elevated position.She knows it was the insert because the broken bone was directly above where the insert was placed.She was placed in an immobilization boot.She had to wear it for 6 weeks to immobilize her foot.After 3 more weeks (relative to (b)(6) 2022), she is to obtain another x-ray to see if her bone was healing or if she needed surgery.She did not have any further medical device identifiers because she cut it out when she opened the package.As of (b)(6) 2022, the consumer noted that if the bone does not heal, she would have to have surgery.On (b)(6) 2022, the consumer saw a new podiatrist.She had three more x-rays taken.She was told there was no change.The podiatrist wanted her to be in the boot for another 5 weeks, then she will be reassessed to see if it is healing or if she needs surgery.The consumer showed the new podiatrist the insert and they discussed the possibility if the product could have caused the fracture.He said it was entirely possible.The patient would like to try bone stimulators to help heal and she was going to ask the podiatrist for his opinion on them.The air cast immobilizer eases her pain, so she did not need to take anything for the pain.The biggest frustration was that it has changed her quality of life.She was used to walking and exercising and now she could not.As of (b)(6) 2022, the air cast immobilizer still hurt some when she tried to walk in it and when she slept.No additional information was provided.

Manufacturer Narrative

The device was not returned.Subsequently no investigation for the device was not possible.

Event Description

On (b)(6) 2022, a spontaneous report from the united states was received from a consumer via telephone regarding a 70-year-old female consumer who used dr.(b)(6) ball of foot pain (lot number and expiration date not provided).Medical history included an allergy to latex and pain in the ball of her foot since (b)(6) 2021.The consumer was noted to be "very fit and walks an hour each day on a flat surface with podiatrist recommended athletic shoes." concomitant products included an unspecified multivitamin.On an unspecified date in (b)(6) 2021, the consumer started using the dr.Scholl's ball of foot pain which she inserted in her left shoe for pain in the ball of her left foot.She did not use an insert in her right shoe.On an unspecified date in (b)(6) 2021, after two weeks of using the dr.(b)(6) ball of foot pain, she developed pain from walking on the ball of her foot.She had never had any foot pain in the past.She was walking on a paved path with good athletic shoes which were designed by podiatrists.She developed pain at the top of her foot.Approximately after the 3rd week of (b)(6) 2022, while she was walking the pain became excruciating and she had to stop walking.Subsequently, she took the insert out and her friend helped her get home.On an unspecified date around the 3rd week of (b)(6) 2022, she had a podiatry appointment.She showed her doctor the insert.The podiatrist examined her foot and took x-rays.She was told that she had broken her 3rd metatarsal bone right at the end point where the insert had arched her foot up.The podiatrist did not say that the insert had anything to do with the fracture, but she felt it did.She thought that using the insert broke her bone as her foot was forced into an abnormal elevated position.She knows it was the insert because the broken bone was directly above where the insert was placed.She was placed in an immobilization boot.She had to wear it for 6 weeks to immobilize her foot.After 3 more weeks (relative to (b)(6) 2022), she was to obtain another x-ray to see if her bone was healing or if she needed surgery.She did not have any further medical device identifiers because she cut it out when she opened the package.As of (b)(6) 2022, the consumer noted that if the bone does not heal, she would have to have surgery.On (b)(6) 2022, the consumer saw a new podiatrist.She had three more x-rays taken.She was told there was no change.The podiatrist wanted her to be in the boot for another 5 weeks, then she will be reassessed to see if it is healing or if she needed surgery.The consumer showed the new podiatrist the insert and they discussed the possibility if the product could have caused the fracture.He said it was entirely possible.The patient would like to try bone stimulators to help heal and she was going to ask the podiatrist for his opinion on them.The air cast immobilizer eases her pain, so she did not need to take anything for the pain.The biggest frustration was that it has changed her quality of life.She was used to walking and exercising and now she could not.As of (b)(6) 2022, the air cast immobilizer still hurt some when she tried to walk in it and when she slept.No additional information was provided.On 27-apr-2022, additional information was received from a consumer.It was learned that on (b)(6) 2022, she saw a third podiatrist and had another x-ray taken.She was told that she could get out of the boot and start gradually walking.She still had pain which woke her up at night.She was told that her toe would be deviated forever and never be straight again.She believed the insert caused her foot problem.The first 2 podiatrist were not able to say the insert caused her foot problem, but the third podiatrist said the insert could have been a contributing factor (not medically verified).No additional information was provided.

Manufacturer Narrative

The device was not returned.Subsequently no investigation for the device was not possible.

Event Description

On 15-feb-2022, a spontaneous report from the united states was received from a consumer via telephone regarding a 70-year-old female consumer who used dr.Scholl's ball of foot pain (lot number and expiration date not provided).Medical history included an allergy to latex and pain in the ball of her foot since (b)(6) 2021.The consumer was noted to be "very fit and walks an hour each day on a flat surface with podiatrist recommended athletic shoes." concomitant products included an unspecified multivitamin.On an unspecified date in (b)(6) 2021, the consumer started using the dr.Scholl's ball of foot pain which she inserted in her left shoe for pain in the ball of her left foot.She did not use an insert in her right shoe.On an unspecified date in (b)(6) 2021, after two weeks of using the dr.Scholl's ball of foot pain, she developed pain from walking on the ball of her foot.She had never had any foot pain in the past.She was walking on a paved path with good athletic shoes which were designed by podiatrists.She developed pain at the top of her foot.Approximately after the 3rd week of (b)(6) 2022, while she was walking the pain became excruciating and she had to stop walking.Subsequently, she took the insert out and her friend helped her get home.On an unspecified date around the 3rd week of (b)(6) 2022, she had a podiatry appointment.She showed her doctor the insert.The podiatrist examined her foot and took x-rays.She was told that she had broken her 3rd metatarsal bone right at the end point where the insert had arched her foot up.The podiatrist did not say that the insert had anything to do with the fracture, but she felt it did.She thought that using the insert broke her bone as her foot was forced into an abnormal elevated position.She knows it was the insert because the broken bone was directly above where the insert was placed.She was placed in an immobilization boot.She had to wear it for 6 weeks to immobilize her foot.After 3 more weeks (relative to (b)(6) 2022), she was to obtain another x-ray to see if her bone was healing or if she needed surgery.She did not have any further medical device identifiers because she cut it out when she opened the package.As of (b)(6) 2022, the consumer noted that if the bone does not heal, she would have to have surgery.On (b)(6) 2022, the consumer saw a new podiatrist.She had three more x-rays taken.She was told there was no change.The podiatrist wanted her to be in the boot for another 5 weeks, then she will be reassessed to see if it is healing or if she needed surgery.The consumer showed the new podiatrist the insert and they discussed the possibility if the product could have caused the fracture.He said it was entirely possible.The patient would like to try bone stimulators to help heal and she was going to ask the podiatrist for his opinion on them.The air cast immobilizer eases her pain, so she did not need to take anything for the pain.The biggest frustration was that it has changed her quality of life.She was used to walking and exercising and now she could not.As of (b)(6) 2022, the air cast immobilizer still hurt some when she tried to walk in it and when she slept.No additional information was provided.On 27-apr-2022, additional information was received from a consumer.It was learned that on (b)(6) 2022, she saw a third podiatrist and had another x-ray taken.She was told that she could get out of the boot and start gradually walking.She still had pain which woke her up at night.She was told that her toe would be deviated forever and never be straight again.She believed the insert caused her foot problem.The first 2 podiatrist were not able to say the insert caused her foot problem, but the third podiatrist said the insert could have been a contributing factor (not medically verified).No additional information was provided.On 23-may-2022, additional information was received from a consumer via the fda (mw5109476).The date of the events was updated to 25-jan-2022.It was clarified that when she used the product she wore it from morning until night.The consumer noted that she was advised that it would taken 9 months to heal entirely.

• Brand Name: DR. SCHOLL'S PAIN RELIEF ORTHOTIC BALL OF FOOT PAIN
• Type of Device: ORTHOTIC
• Manufacturer (Section D): DONGGUAN YUN CHANG PLASTIC CO., LTD.; no. 15, dong north road,; dong chen street; doungguan city, guangdong 52312 7; CH 523127
• Manufacturer (Section G): SCHOLL'S WELLNESS COMPANY; 119 cherry hill road,; suite200; parsippany NJ 07054
• Manufacturer Contact: alex terranova ; 119 cherry hill road,; suite 200; parsippany, NJ 07054 ; 8623281407
• MDR Report Key: 13652569
• MDR Text Key: 286670268
• Report Number: 3004898984-2022-00001
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2022
• 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
• Treatment: UNSPECIFIED MULTIVITAMIN; UNSPECIFIED MULTIVITAMIN; UNSPECIFIED MULTIVITAMIN
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 54 KG