FDA Adverse Event Injury Summary report: N

IODOSORB IODINE GEL

MDR report key: 22106084 · Received May 29, 2025

Report

Report Number
MW5170872
Event Type
Injury
Date Received
May 29, 2025
Date of Event
June 18, 2024
Manufacturer
SMITH & NEPHEW MEDICAL LTD
Product Code
FRO
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
VA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I WAS GIVEN IODOSORB IODINE GEL MANUFACTURER SMITH AND NEPHEW. IT WAS TO HEAL MY OPEN WOUND BUT INSTEAD IT BOAR A BIGGER WOUND IN JUST 2 DAYS. I SUBMITTED TO YOU THIS BEFORE AND GOT NO RESPONSE. I CONTACTED THIS MANUFACTURER, AND I WAS ACCOMMODATED TO A VIDEO MEETING AND WAS ASKED TO SUBMIT MY (B)(6) HOSPITAL WOUNDCARE MEDICAL RECORDS AND I DID AND STRANGELY I REALLY WANT TO KNOW WHY SUCH A REACTION OCCURRED, I'M NOT ALLERGIC TO IODINE, BUT I DO SUFFER GREATLY WITH MEDICAL UNDERLYING CONDITIONS. I'D LIKE TO KNOW COULD A COMBINATION OF CHEMICALS RELATED TO MY NEUROSARCOIDOSIS HAVE CAUSED SUCH A REACTION AND WHAT ELSE SHOULD I BE ON THE LOOK-OUT FOR THAT WAS ONCE HARMLESS TO ME. CAN YOU BE OF SOME HELP AS SMITH AND NEPHEW SEEM TO HAVE FORGOTTEN ME AS I MUST CONTINUE TO FILL OUT THERE ONLINE GRIEVANCE FORM JUST TO GET THERE ATTENTION. CONCERNING THE ALENDRANATE SODIUM TABLET, I HAVE ACQUIRED SOLID CRYTAL FORMATIONS JUST BELOW ME SKIN AS ONE WAS EXTRACTED IN WOUNDCARE. THESE CRYSTALS HAVE PLAGUED MY LIFE FOR YEARS AS I AM MEDICALLY TOLD THEY MEAN NOTHING UNTIL I WAS EXERCISED UPON AS SAID FOR A PULMONARY EMBOLISM (B)(6) 2024 (B)(6) HOSPITAL. THESE CRYSTALS SEEM TO HAVE TAKEN TO MY MEDICAL UNDERLYING CONDITIONS. MIXING TOGETHER FORMING THESE CRYSTALS. I ALMOST BEGGED FOR THEM TO BE CUT OUT TO EASE MY PAIN OF THEM WANTING TO BURST THROUGH MY SKIN. I FEEL ALENDRONATE MAY HAVE FORMED INTO THESE CRYSTALS AND NOT ALONE AS THEY ARE ALL OVER WITHIN MY BODY. WHAT IS A PERSON TO DO WHEN DO TORS HAVE NO ANSWER? ALENDRONATE SODIUM TABLETS ARE NOT OF SMITH AND NEPHEW BUT ARE WHAT I SEE AS LIFE-THREATENING. IF YOU DON'T COMMUNICATE WITH ME, THEN YOU'RE NOT HELPING ME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
36243 IODOSORB IODINE GEL DRESSING, WOUND, DRUG FRO SMITH & NEPHEW MEDICAL LTD

Patients

Seq Age Sex Outcome Treatment
1 60 YR Male Other| L| R ALENDRONATE SODIUM TABLETS 70MG.| MILK THISTLE. | PREDNISONE. | SYNTHORID. | VITAMIN D, C AND E.