MAUDE Adverse Event Report: MEDEX/PSI PREMIER SPECIALITIES / DJO GLOBAL ARMBAND PNEUMATIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 09/13/2016

Event Type  Injury  

Event Description

I was prescribed an armband pneumatic brace from med ex/psi premier specialities inc., and after wearing it for a few weeks.I developed a rash and intense itching in the area on the top of the forearm where the brace was.Although i have not used it since (b)(4).I still have visible skin changes and itching.

• Brand Name: ARMBAND PNEUMATIC
• Type of Device: ARMBAND PNEUMATIC
• Manufacturer (Section D): MEDEX/PSI PREMIER SPECIALITIES / DJO GLOBAL
• MDR Report Key: 6025440
• MDR Text Key: 57468073
• Report Number: MW5065363
• Device Sequence Number: 1
• Product Code: NGX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/10/2016

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ATACAND; ATENOLOL; CYCLAFEM; FLUOXETINE; MOBIC; VIT D
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 79