MAUDE Adverse Event Report: SMITHS MEDICAL, INC BELLAFILL; IMPLANT, DERMAL, FDR AESTHETIC USE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Irritation (1941); Swelling (2091); Burning Sensation (2146)

Event Date 06/26/2019

Event Type  Injury  

Event Description

Bellafill was put under eyes.Swelling irritation and burning noted 1 year after.Fda safety report id# (b)(4).

• Brand Name: BELLAFILL
• Type of Device: IMPLANT, DERMAL, FDR AESTHETIC USE
• Manufacturer (Section D): SMITHS MEDICAL, INC
• MDR Report Key: 8861325
• MDR Text Key: 153427633
• Report Number: MW5088754
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 61