MAUDE Adverse Event Report: MSD CONSUMER CARE, INC. DR.SCHOLL'S HEEL PAIN RELIEF ORTHOTICS - MEN; ORTHOSIS, CORRECTIVE SHOE

Device Problem Product Quality Problem (1506)

Patient Problem Myocardial Infarction (1969)

Event Type  Other  

Event Description

Event verbatim (lower level term).Had a heart attack.The underside purple circle came out (product quality issue).Case description: this spontaneous report originating from the united states as received from a consumer refers to a male patient of unknown age.This report concerns 1 patient and 1 device.The patient used the orthotic (dr.Scholl's heel pain relief orthotics - men's) for an unknown indication.No other co-suspects were reported.No concomitant medications were reported.On an unknown date, the patient had a heart attack (medically significant) and the underside purple circle came out.No treatment information was reported.The orthotic (dr.Scholl's heel pain relief orthotics - men's) was discontinued.The outcome of the events was unknown.The reporter considered the underside purple circle coming out to be not related to the orthotic (dr.Scholl's heel pain relief orthotics - men's).

Manufacturer Narrative

(b)(4).The relatedness for the patient having a heart attack was unknown for the orthotic (dr.Scholl's heel pain relief orthotics - men's).The orthotic (dr.Scholl's heel pain relief orthotics - men's) was not available for investigation.For the orthotic (dr.Scholl's heel pain relief orthotics - men's), the lot number was not available and the serial number was not available.Additional information was not expected.

• Brand Name: DR.SCHOLL'S HEEL PAIN RELIEF ORTHOTICS - MEN
• Type of Device: ORTHOSIS, CORRECTIVE SHOE
• Manufacturer (Section G): MSD CONSUMER CARE, INC.; 4207 michigan avenue rd. n.e.; cleveland TN 37323
• Manufacturer Contact: merck ; p.o box 4; west point, PA 19486-0004 ; 2156527905
• MDR Report Key: 4379911
• MDR Text Key: 15320726
• Report Number: 1031623-2014-00013
• 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
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• 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: 12/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other