FDA Adverse Event Injury Summary report: N

AART GLUTEAL IMPLANT

MDR report key: 19762838 · Received July 17, 2024

Report

Report Number: 3003897287-2022-01320
Event Type: Injury
Date Received: July 17, 2024
Date of Event: November 30, 2019
Report Date: June 1, 2026
Manufacturer: DSAART, LLC
Product Code: MIB
PMA / PMN Number: K021839
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NV, US
Reporter Occupation: 501

Narratives

Additional Manufacturer Narrative · 0

PATIENT RETURNED TO DOCTOR IN (B)(6) 2018 DUE TO SWELLING. DOCTOR DETERMINED A SERMONA AND TREATED PATIENT. PATIENT RETURNED SEVERAL MORE TIMES THROUGH-OUT 2019 FOR SAME REASON. LEFT IMPLANT REMOVED (B)(6) 2019. DURING PROCEDURE DOCTOR FOUND THAT THE IMPLANT HAD FOLDED AND THERE WAS A CRACK IN IT. PATIENT REQUESTED DOCTOR REPLACE AT A LATER DATE. (B)(6) 2020 PATIENT RETURNED FOR REPLACEMENT IMPLANT. SUBSEQUENT FOLLOW UP WITH DOCTOR REVEALED NO FURTHER ISSUES WITH THIS PATIENT VERIFY PRODUCT ORDERED WAS WHAT WAS SHIPPED UNABLE TO PERFORM ANY TESTING OR EXAMINE IMPLANTS AS IT WAS REMOVED AND DESTROYED PRIOR TO CONTACTING US REVIEW OF PREVIOUS COMPLAINTS FROM 2018 TO PRESENT DETERMINED THAT THERE WERE NO OTHER COMPLAINTS OF THIS NATURE REPORTED.

Description of Event or Problem · 0

DOCTORS OFFICE CALLED FOR REPLACEMENT IMPLANT FOR A PATIENT WHO HAD ONE REMOVED DUE TO SWELLING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2149655	AART GLUTEAL IMPLANT	GLUTEAL IMPLANT	MIB	DSAART, LLC		13-04-008

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Female	Required Intervention