FDA Adverse Event Injury Summary report: N

MENTOR SMOOTH ROUND MODERATE PROFILE

MDR report key: 8840965 · Received July 30, 2019

Report

Report Number: 1645337-2019-16100
Event Type: Injury
Date Received: July 30, 2019
Date of Event: June 17, 2019
Report Date: July 8, 2019
Manufacturer: MENTOR TEXAS
Product Code: FWM
UDI-DI: 00081317001195
PMA / PMN Number: P990075
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: LEFT SIDE BREAST IMPLANT RUPTURE. CONCOMITANT MEDICAL PRODUCTS: RIGHT SIDE; 250CC MENTOR SMOOTH ROUND MODERATE PROFILE; CATALOG NUMBER: 3501635; LOT NUMBER: 190898. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT A (B)(6) PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 175CC MENTOR SMOOTH ROUND MODERATE PROFILE AND WAS PRESENTED WITH LEFT SIDE BREAST IMPLANT RUPTURE. AS A RESULT, THE DEVICE WAS EXPLANTED, AND REPLACED WITH CATALOG NUMBER SHPX465 ON (B)(6)2019.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
636149	MENTOR SMOOTH ROUND MODERATE PROFILE	PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE	FWM	MENTOR TEXAS		189455	00081317001195

Patients

Seq	Age	Sex	Outcome	Treatment
1	44 YR		Required Intervention