OtherKCZ

BRAVA BRA

Received Mar 1, 2002 · Event occurred Dec 1, 2001

Report MW1024232 · MDR key 380305

Device

Generic name

Breast Enlargement

Manufacturer

Brava, Llc

Model number

Catalog number

Lot number

UNK

Product problems

Patient

51 YR

Blister(s)

Narrative

Description of Event or Problem

BRAVA BRAS SELLS A CLASS 11 MEDICAL DEVICE TO ENLARGE BREASTS. A LOCAL DR AND RPTR BOTH TRIED IT AND BOTH DEVELOPED BLISTERS ON BREASTS. WHEN RPTR CALLED TO COMPLAIN THE PERSON WHO ANSWERED THE PHONE SAID THEY DID TOO. HOW CAN WE FORCE THE MFR TO WARN OR IMPROVE THIS PRODUCT?