FDA Adverse Event Injury Summary report: N

RESTYLANE-L

MDR report key: 4265468 · Received November 12, 2014

Report

Report Number: MW5039112
Event Type: Injury
Date Received: November 12, 2014
Date of Event: October 3, 2014
Report Date: November 12, 2014
Manufacturer: GALDERMA
Product Code: LMH
Product Problem: Yes
Report Source: Voluntary report
Reporter Occupation: PHYSICIAN

Narratives

Description of Event or Problem · 1

A (B)(6) FEMALE INJECTED WITH 1ML OF RESTYLANE USING MICRO-CANNULA FOR TEAR TROUGHS, 0.5 UNDER EACH SIDE. NOTE: PATIENT HAS RECEIVED SAME TREATMENT, SAME PRODUCT 3 TIMES IN THE PAST AT OUR PRACTICE WITHOUT INCIDENT. PATIENT EXPERIENCED SEVERE SWELLING, PAIN, ERETHYMA WITHIN A FEW HOURS OF INJECTION. HER EYES SWELLED SHUT AND PT. WAS PRESCRIBED 20 MGS OF PREDNISONE AND 50MGS OF BENADRYL. SIX WEEKS LATER PATIENT STILL HAS SOME SWELLING AND NODULES. THIS WAS A NEW LOT OF RESTYLANE HAD RECENTLY RECEIVED AND EVERY PATIENT INJECTED EXPERIENCED SIMILAR REACTIONS. WE SENT BACK THE REMAINING PRODUCT TO THE COMPANY FOR ANALYSIS BUT COMPANY IS GIVING US THE RUN AROUND SAYING NO ONE ELSE IS HAVING THIS HAPPEN. I KNOW FOR FACT THIS IS NOT TRUE. BEWARE USING RESTYLANE ON YOUR PATIENTS UNTIL THE COMPANY ACKNOWLEDGES THERE IS CURRENTLY A MANUFACTURING ISSUE WITH SOME OF THEIR LOTS. WE HAVE BEEN USING RESTYLANE FOR YEARS AND THIS IS THE FIRST TIME SOMETHING LIKE THIS HAS EVER HAPPENED. SAME REPORTER FOR MW5039112 - MW5039116.

Description of Event or Problem · 1

ADD'L INFO RECEIVED FROM REPORTER ON 05/22/2015. THESE REPORTS WERE ORIGINALLY RECEIVED AND PROCESSED BY (B)(4) NORTH AMERICA LLC, THE PRIOR OWNER OF RESTYLANE-L. IT WAS DETERMINED THAT NONE OF THESE CASES REQUIRED A MEDICAL DEVICE REPORT (MDR).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
729823	RESTYLANE-L	RESTYLANE-L	LMH	GALDERMA		12399

Patients

Seq	Age	Sex	Outcome	Treatment
1	45 YR		Required Intervention