MOLE REMOVER PEN
Received Mar 31, 2022 · Event occurred Mar 3, 2022
Report MW5108715 · MDR key 13977276
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
32 MO · Male
- Hemorrhage/Blood Loss/Bleeding
- Skin Burning Sensation
- Hemorrhage/Blood Loss/Bleeding
- Skin Burning Sensation
Narrative
Description of Event or Problem
I BOUGHT THIS MOLE REMOVER PEN ON (B)(6)? STARTED BLEEDING AFTER JUST A FEW TRIES AND WITHIN A FEW HOURS, I COULD FEEL MY SKIN BURNING. I TRIED TO CONTACT HIM WITH THE EMAIL ADDRESS LEFT BY THE SELLER AND ASKED HIM TO PROVIDE ME WITH FDA DOCUMENTS, BUT THE SELLER IGNORED ME. I SEARCHED FOR INFORMATION. THIS PRODUCT BELONGS TO A SECOND-CLASS PRESCRIPTION MEDICAL DEVICES, I CAN'T BELIEVE (B)(6) SELLS SUCH A DANGEROUS PRODUCT. SUCH A DANGEROUS PRODUCT SHOULD NOT BE SOLD IN THE US, I SEE THIS PRODUCT IS VERY POPULAR, PLEASE CHECK IF THIS PRODUCT IS APPROVED BY THE FDA, IF IT IS NOT PLEASE PUNISH (B)(6) AND THIS (B)(6) SELLER, IT SHOULD NOT ALLOW THIS SELLER TO SELL NON-COMPLIANT PRODUCTS MANUFACTURER WEBSITE (B)(6). DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT? NO. DID THE PROBLEM RETURN IF THE PERSON STARTED TAKING OR USING THE PRODUCT AGAIN? YES. BIAOLING. FDA SAFETY REPORT ID # (B)(4).