MAUDE Adverse Event Report: MSD CONSUMER CARE, INC. DR. SCHOLL'S CUSTOM FIT ORTHOTICS CF 310; ORTHOSIS, CORRECTIVE SHOE

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Event verbatim (lower level term).Knee surgery (knee operation).Case description: this spontaneous report originating from the united states as received from a consumer refers to a female pt of unk age.This report concerns 1 pt and 1 device.The pt used the orthotic (dr.Scholl's custom fit orthotics cf 310) for an unk indication.No other co-suspects were reported.No concomitant medications were reported.On an unk date, the pt had knee surgery (medically significant).No treatment info was reported.The action taken and the outcome were unk.The relatedness for the pt having knee surgery was unk for the orthotic (dr.Scholl's custom fit orthotics cf 310).The orthotic (dr.Scholl's custom fit orthotics cf 310) was not available for investigation.For the orthotic (dr.Scholl's customer fit orthotics cf 310), the lot number was not available and the serial number was not available.Add'l info was not expected.

Manufacturer Narrative

(b)(4).

• Brand Name: DR. SCHOLL'S CUSTOM FIT ORTHOTICS CF 310
• Type of Device: ORTHOSIS, CORRECTIVE SHOE
• Manufacturer (Section G): MSD CONSUMER CARE, INC.; 4207 michigan avenue rd. n.e.; cleveland TN 37323
• Manufacturer Contact: po box 4; west point, PA 19486-0004 ; 2156527905
• MDR Report Key: 4440109
• MDR Text Key: 5310815
• Report Number: 1031623-2015-00001
• 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
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2015
• 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: 01/14/2015
• 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