MAUDE Adverse Event Report: DSAART, LLC., DBA ALPHA AESTHETICS PECTORAL IMPLANT; IMPLANT, MUSCLE, PECTORALIS

Model Number	B
Health Effect - Clinical Code	Seroma (2069)
Date of Event	01/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient having reoccurring seromas requested replacement implant.Implant was removed and destroyed prior to contacting us about complaint.All relevant information regarding complaint acquired from doctor.On (b)(6) 2019, patient developed seroma; (b)(6) 2019 pt returned, implant adjusted (b)(6) 2019.Drain place for continued seroma (b)(6) 2019.Implant removed (b)(6) 2020 contacted us for replacement implant.Patient developed seroma post - op.Continued seromas required implant removal and replacement unable to examine or perform testing on explanted product.Doctor removed and destroyed prior to contacting us for replacement.Fda safety report id # (b)(4).

• Brand Name: PECTORAL IMPLANT
• Common Device Name: IMPLANT, MUSCLE, PECTORALIS
• Manufacturer (Section D): DSAART, LLC., DBA ALPHA AESTHETICS; carson city NV 89706
• MDR Report Key: 15562682
• Report Number: MW5112484
• Device Sequence Number: 2780570
• Product Code: MIC
• UDI-Device Identifier: B4905002035B0
• UDI-Public: B4905002035B0
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: B
• Device Catalogue Number: 500-203-5B
• Device Lot Number: 18-10-011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GLUTEAL IMPLANT: (B)(6) 2019-(B)(6) 2019
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown