MAUDE Adverse Event Report: MSD CONSUMER CARE, INC. DR SCHOLL'S BALL OF FOOT PAIN RELIEF ORTHOTICS; ORTHOSIS

Device Problem Insufficient Information (3190)

Patient Problems Therapeutic Response, Decreased (2271); Inadequate Pain Relief (2388)

Event Type  Other  

Event Description

Case description: this spontaneous report originating from (b)(6) as received from a consumer referring to her daughter (female patient of unknown age).The patient used foot cushion (dr.Scholl's ball of foot pain relief orthotics) for unspecified indication.On an unknown date the following event(s) occurred: it did not relieve the pain, it did not work and an operation on the foot was needed (medically significant).It was specified that the patient works in a hospital and she wore it for four and a half weeks and found no pain relief.After consultation with her foot doctor, the patient found out that an operation on the foot was needed.The outcome of it did not relieve the pain, it did not work and an operation on the foot was needed is unknown.It is unknown if the events are related to foot cushion (dr.Scholl's ball of foot pain relief orthotics).

Manufacturer Narrative

The foot cushion (dr.School's ball of foot pain relief orthotics) was available for investigation and returned to manufacturer on 31-jul-2014.For foot cushion (dr.Scholl's ball of foot pain relief orthotics), the lot number is not available and the serial number is not available.Additional information is not expected.

• Brand Name: DR SCHOLL'S BALL OF FOOT PAIN RELIEF ORTHOTICS
• Type of Device: ORTHOSIS
• Manufacturer (Section G): MSD CONSUMER CARE, INC.; 4207 michigan avenue rd ne; cleveland TN 37323
• Manufacturer Contact: po box 4; west point, PA 19486-0004 ; 2156527905
• MDR Report Key: 4053432
• MDR Text Key: 4737387
• Report Number: 1031623-2014-00007
• Device Sequence Number: 1
• Product Code: KNP
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/31/2014

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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/31/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/31/2014
• Initial Date FDA Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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