MAUDE Adverse Event Report: MSD CONSUMER CARE, INC. DR SCHOLL'S PAIN RELIEF ORTHOTICS (PRO) FOR ARCH; ORTHOSIS, CORRECTIVE SHOE (KNP)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Headache (1880); Neurological Deficit/Dysfunction (1982); Pain (1994); Sprain (2083); Concussion (2192)

Event Type  Other  

Event Description

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 (b)(6)s pain relief orthotics (pro) for arch, womens) for an unk indication.No other co-suspects were reported.No concomitant medications were reported.On an unk date the pt experienced an accident which caused her to have multiple fractures of the orbital bone of her left eye and a broken nose (medically significant).She had many sprains and a great deal of pain, and she further reported that she has post-concussion syndrome causing loss of balance and headaches.No treatment info was reported.The action taken on the product was unk.The outcome of the pt's multiple fractures of the orbital bone, broken nose, accident, headaches, pain, sprains and loss of balance were unk.The outcome of the pt's post-concussion syndrome was reported as not recovered/not resolved.The pt's multiple fractures of the orbital bone, broken nose, headaches, loss of balance, post-concussion syndrome, pain, sprains and accident were considered to be not related to the orthotic (dr (b)(6)'s pain relief orthotics (pro) for arch, womens).The reporter considered the product not helping to be related to the orthotic (dr (b)(6)'s pain relief orthotics (pro) for arch, womens).The orthotic (dr (b)(6)'s pain relief orthotics (pro) for arch, womens) was available for the investigation.For the orthotic (dr (b)(6)'s pain relief orthotics (pro) for arch, womens), the lot number was not available and the serial number was not available.Additional info was not expected.

Manufacturer Narrative

Post concussion syndrome (post concussion syndrome), loss of balance (equilibrium loss), sprains (sprain), great deal of pain (pain), headaches (headache), accident (accident), not helpful to me (therapeutic product ineffective).(b)(4).

• Brand Name: DR SCHOLL'S PAIN RELIEF ORTHOTICS (PRO) FOR ARCH
• Type of Device: ORTHOSIS, CORRECTIVE SHOE (KNP)
• 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: 4184040
• MDR Text Key: 5094599
• Report Number: 1031623-2014-00011
• 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: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2014
• 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
• Patient Outcome(s): Other