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

Device Problem Insufficient Information (3190)

Patient Problems Rupture (2208); Injury (2348)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of medical device site injury ("it causse mt planta fascie to rupture caused me to have surgery") in a male patient who received dr scholls custom fit orthotic inserts 430 for pain and discomfort.On an unknown date, the patient started dr scholls custom fit orthotic inserts 430.On an unknown date, the patient experienced medical device site injury (seriousness criteria medically significant and intervention required).The patient was treated with surgery.It was unknown whether any action was taken with dr scholls custom fit orthotic inserts 430.At the time of the report, the medical device site injury outcome was unknown.The reporter considered medical device site injury to be related to dr scholls custom fit orthotic inserts 430.Most recent follow-up information incorporated above includes: on (b)(6) 2017: suspect product was revised to dr scholls custom fit orthotic inserts 430 (instead of previously reported 410).Moreover, case was also considered serious due to intervention required.This spontaneous case was reported by a consumer and describes the occurrence of medical device site injury ("it causse mt planta fascie to rupture caused me to have surgery") in a male patient who received dr scholls custom fit orthotic inserts for pain and discomfort.The reported event is serious due to medical significance, required intervention and is unlisted in the reference safety information of dr scholls custom fit orthotic inserts.Considering the implied temporal association and the fact, that the suspect device may have an effect on the plantar fascia due to close spatial proximity and arch support, company conservatively considers the causality to be related.It is important to note, that such a rupture is more likely to occur in patient's with chronic plantar fasciitis and/or diabetes, overweight or recipients of corticosteroid therapy.In this case no information was reported on risk factors.This case was regarded as incident.

Manufacturer Narrative

This spontaneous case was reported by a consumer and describes the occurrence of medical device site injury ("it causse mt planta fascie to rupture caused me to have surgery") in a male patient who received dr scholls custom fit orthotic inserts 430 for pain and discomfort.On an unknown date, the patient started dr scholls custom fit orthotic inserts 430.On an unknown date, the patient experienced medical device site injury (seriousness criteria medically significant and intervention required).The patient was treated with surgery.It was unknown whether any action was taken with dr scholls custom fit orthotic inserts 430.At the time of the report, the medical device site injury outcome was unknown.The reporter considered medical device site injury to be related to dr scholls custom fit orthotic inserts 430.Quality-safety evaluation of ptc: based on the technical investigation, a review of the device history was conducted and no defects were identified during the manufacture of the device.All dr.Scholl's custom fit orthotics 410 are made in accordance with current good manufacturing practices and to the applicable fda and iso regulations.All product undergoes 100% inspection throughout the manufacturing process where the associated data and documentation is reviewed to ensure all released product meets product specifications.A thorough ptc investigation cannot be conducted by the quality unit as a batch number or sample was not provided.A quality defect could not be confirmed.Most recent follow-up information incorporated above includes: on 13-dec-2017: quality-safety evaluation of ptc: unconfirmed quality defect risk category v.This spontaneous case was reported by a consumer and describes the occurrence of medical device site injury ("it causse mt planta fascie to rupture caused me to have surgery") in a male patient who received dr scholls custom fit orthotic inserts for pain and discomfort.The reported event is serious due to medical significance, required intervention and is unlisted in the reference safety information of dr scholls custom fit orthotic inserts.Considering the implied temporal association and the fact, that the suspect device may have an effect on the plantar fascia due to close spatial proximity and arch support, company conservatively considers the causality to be related.It is important to note, that such a rupture is more likely to occur in patient's with chronic plantar fasciitis and/or diabetes, overweight or recipients of corticosteroid therapy.In this case no information was reported on risk factors.This case was regarded as incident.Quality-safety evaluation of ptc: unconfirmed quality defect risk category v.

• Brand Name: DR SCHOLLS
• Type of Device: ORTHOSIS, CORRECTIVE SHOE
• Manufacturer (Section D): BAYER HEALTHCARE LLC, CONSUMER CARE; 36 columbia road; morristown NJ 07960
• Manufacturer (Section G): BAYER HEALTHCARE LLC, CONSUMER CARE; 36 columbia road; morristown NJ 07960
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 7060847
• MDR Text Key: 93029209
• Report Number: 2248903-2017-00001
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention