FDA Adverse Event Injury Summary report: N

SCARAWAY SILICONE CLEAR SCAR SHEET

MDR report key: 22534537 · Received July 17, 2025

Report

Report Number
MW5172877
Event Type
Injury
Date Received
July 17, 2025
Date of Event
May 14, 2025
Report Date
July 14, 2025
Manufacturer
ALLIANCE PHARMA, INC
Product Code
MDA
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I WENT TO A HAND PHYSICAL THERAPIST FOR A SCAR THAT WAS NOT HEALING PROPERLY AFTER CARPAL TUNNEL SURGERY - MY DOCTOR PUT IN THE REFERRAL. THE THERAPIST USED A SILICONE STRIP ON MY HAND, AND IT SOFTENED THE SCAR. SHE GAVE ME A SAMPLE AND TOLD ME TO BUY SCARAWAY AND TO PUT ON STRIPS AT NIGHT. MY HUSBAND WENT ON-LINE AND ORDERED A BOX FROM WALMART AS IT HAD FREE DELIVERY. MEANWHILE, MY HAND WAS HEALING, AND THE SCAR WAS NO LONGER AS HARD AND HAD BECOME FLATTER. THE THERAPIST RECOMMENDED SCARAWAY - I THOUGHT THAT WAS WHAT WAS BEING USED. WHEN THE SCARAWAY FROM WALMART CAME, I USED IT ON MY HAND. MY HAND BECAME INFLAMED, A SORE RED MOUND DEVELOPED IN MY PALM, AND IT WAS PAINFUL. UNFORTUNATELY, THAT NIGHT (BEFORE THE REACTION ON THE PALM SET IN) I READ IN THE PRODUCT'S INSERT THAT SCARAWAY CAN BE USED "ON ANY PART OF THE BODY" - SO I DECIDED TO TRY IT ON A SCAR NEAR MY EYEBROW THAT HAS BOTHERED ME AND USED A SMALL STRIP THERE OVERNIGHT. SCARAWAY SAYS IT CAN BE SAFELY USED 12-24 HOURS - I REMOVED AFTER 7. THE EDGES OF THE STRIP LEFT DEEP GROOVES IN MY FOREHEAD BETWEEN MY EYES, PUSHED MY SKIN SO I DEVELOPED A RECTANGULAR SHAPE WRINKLE BOX OVER MY RIGHT EYEBROW, AND PRODUCED LINES ON THE BRIDGE OF MY NOSE AND FOREHEAD. I WENT TO THE DOCTOR AND GOT STEROID CREAM FOR MY PALM - AFTER 2 WEEKS OF PAIN, IT IMPROVED. I WENT TO A DERMATOLOGIST FOR MY FACE, AND SHE PRESCRIBED RETINOL CREAM - NO CHANGE OR RELIEF. THE LINES ARE SO DEEP THAT SHE DOUBTS THAT PLASTIC SURGERY CAN HELP ME!! I FOUND OUT LATER THAT THE THERAPIST PUT CICA-CARE ON MY HAND - IT WORKED WELL. SCARAWAY GAVE ME PAIN AND MESSED UP MY FACE. ALL SILICONE STRIPS ARE NOT ALIKE. THE SCARAWAY STRIP INSERT SHOULD SAY TEST FOR AN ALLERGIC REACTION. I FOUND OTHER PEOPLE WITH TROUBLES LIKE MINE IN AMAZON REVIEWS DURING JUNE. I WISH I COULD HAVE SAVED THEM. PLEASE MAKE SCARAWAY STATE ON THE INSERT TO TEST AND BE CAREFUL WHEN USED ON THE FACE!! I DON'T WANT OTHERS TO EXPERIENCE ALL MY PAIN AND THE AGONY OF PAYING FOR A PRODUCT THAT HARMS THEM. I CANNOT EVEN GET A REFUND FROM SCARAWAY AS THEY SAY THE 60-DAY GUARANTEE DOES NOT APPLY TO ONLINE PURCHASES FROM WALMART - ONLY FROM THEIR AMAZON SITE ONLINE. I HAVE HAD DOCTOR BILLS, PRESCRIPTION BILLS, AND MUCH AGONY - THEY ARE GETTING OFF WITHOUT ANY RESPONSIBILITY TO SAFEGUARD OTHERS. THE DOCTORS AND HAND THERAPIST I SAW CAN VERIFY WHAT I AM REPORTING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2752054 SCARAWAY SILICONE CLEAR SCAR SHEET ELASTOMER, SILICONE, FOR SCAR MANAGEMENT MDA ALLIANCE PHARMA, INC

Patients

Seq Age Sex Outcome Treatment
1 76 YR Female ALLEGRA.| CALCIUM.| COQ 10.| FLONASE.| GLUCOSAMINE CHONDROITIN.| LEVOTHYROXINE.| MONTELUKAST.| PROBIOTIC.| RECLAST.| SIMVASTATIN.| SUDAFED.| VOLAREN.| ZINC.