MalfunctionOUB
MIRADRY BIOTIP
Received Apr 19, 2022 · Event occurred Mar 21, 2022
Report 3008082710-2022-70012 · MDR key 14148446
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4500-BTLot number
222
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
RECEIVED COMPLAINT FROM CUSTOMERS THAT 4 OF 12 BIOTIPS THEY RECEIVED WERE USED AND BLOODY. PER CONFIRMATION OF THE SALES REP, THE BIOTIPS DID NOT DIRECTLY COME FROM MIRADRY PERSONNEL.
Additional Manufacturer Narrative
CONFIRMATION OF THE SALES REP INDICATED THE BIOTIPS DID NOT DIRECTLY COME FROM MIRADRY PERSONNEL.