FDA Adverse Event Injury Summary report: N

FRACTORA

MDR report key: 7628852 · Received June 21, 2018

Report

Report Number
MW5077994
Event Type
Injury
Date Received
June 21, 2018
Date of Event
April 25, 2016
Report Date
June 20, 2018
Manufacturer
INMODE MD LTD.
Product Code
GEI
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
OR, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

DECIDED TO SEE DR (B)(6) FOR FILTER BUT WHEN SHE SAID THERE COULD BE POSSIBLE SWELLING AND DOWNTIME DUE TO MY WORK SCHEDULE AND VACATION A WEEK AWAY, SHE RECOMMENDED LASER. I WAS REFERRED TO DR (B)(6), BY A MUTUAL CLIENT WHO HAD RECEIVED LASER TREATMENTS BY DR (B)(6). DR (B)(6) HAD RECOMMENDED LASER TX TO MY EYE AREA FOR SKIN REJUVENATION STATING IT REQUIRED NO DOWNTIME, BUT A SERIES OF TREATMENT. DURING LASER TX, I EXPERIENCED UNBEARABLE PAIN. AFTER FINISHING LASER PROCEDURE, SHE WROTE ON A POST IT TO TAKE BROMELAIN AND/OR TEA BAGS TO HELP MINIMIZE POSSIBLE SWELLING. I HAD EXCESSIVE SWELLING AND PAIN. DAYS TO FOLLOW THE SWELLING STARTED TO SUBSIDE A LITTLE AND I STARTED TO SEE RED, CLAW-LIKE, RAISED + OPEN MARKS AROUND MY EYES, WHICH WORSENED OVER THE NEXT WEEK. ON DAY THREE, I SENT HER PICS TO VERIFY THIS WAS NORMAL, SHE CONFIRMED YES AND TO CONTINUE TAKING THE BROMELAIN. APPROX SIX DAYS LATER SENT MORE PICS AND MARKS WHERE STILL VERY VISIBLE AND RAW. SHE AGAIN ASSURED ME THIS WAS NORMAL AND NOTHING TO WORRY ABOUT BUT WOULD BRING ME SOME CREAMS TO HELP HEALING AND SUNSCREEN. AFTER A COUPLE WEEKS OF DOWNTIME, I ASKED HER WHAT LASER WAS USED. SHE TOLD ME SHE USED FRACTORA. SHE RECOMMENDED A SECOND LASER TREATMENT, WHICH SHE COMPLETED. DURING THAT APPT, I VOICED MY CONCERNS REGARDING THE RAISED RED MARKS, SWELLING AND LENGTHY DOWNTIME. THE REDNESS CONTINUED, ALONG WITH SWELLING, CLAW-LIKE MARKS AND DISCOMFORT. I SAW DR (B)(6), WHO EVALUATED THE MARKS AND TOLD ME HE COULDN'T HELP ME, BUT TO ALLOW IT TO HEAL. HE RECOMMENDED FOR ME TO GIVE IT 1-1.5 YRS FOR HEALING PROCESS. HE ALSO RECOMMENDED, I SEE ANOTHER SPECIALIST, WHICH I DID. I SAW DR (B)(6). UPON EXAMINATION, DR (B)(6) SAID THERE HAS BEEN AN ERROR MADE. HIS RECOMMENDATION WAS TO APPLY PROSILK, SUNSCREEN AND AVOID SUN EXPOSURE. HE ALSO, STATED FULL TISSUE RECOVERY WOULD TAKE APPROX 1 - 1.5 YRS TO REEVALUATE THE EXTENT OF DAMAGE AND RECOVERY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
468572 FRACTORA ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI INMODE MD LTD.

Patients

Seq Age Sex Outcome Treatment
1 48 YR Required Intervention