EXPRESSION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-10 for EXPRESSION manufactured by Enhancement Medical.

Event Text Entries

[20322711] On (b)(6) 2014 i was injected with expression in both cheek areas as a wrinkle reducer by dr. (b)(6) 9a board certified plastic surgeon. I have never used this product before. Within a few days my cheek bone area became swollen and red, itchy and hard especially, my left side. The swelling increased daily. I called his office on (b)(6). He was away and his staff contacted him and he advised warm compresses. On (b)(6) the left side facial swelling was so bad my eye was almost closed. I went to an emergency room and was diagnosed with cellulitis not an allergic reaction but yet prescribed 500 mg of keflex. Prior to my injection i was told by dr. (b)(6) that the expression was not fda approved just as most injectables were not. At my recent visit he told me that i was only the third person to have a reaction. The keflex seems to be working as well and the swelling has diminished slightly especially around the eye areas.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5039089
• MDR Report Key: 4254833
• Date Received: 2014-11-10
• Date of Report: 2014-11-10
• Date of Event: 2014-10-29
• Date Added to Maude: 2014-11-18
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EXPRESSION
• Generic Name: WRINKLE REDUCER
• Product Code: OHS
• Date Received: 2014-11-10
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ENHANCEMENT MEDICAL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2014-11-10