MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT

Catalog Number	350-5535BC
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Since no lot number was provided, no device history record (dhr) review could be performed.(b)(4).Biosense webster manufacturer report numbers 1645337-2017-00116 / 1645337-2017-00115 / 1645337-2017-00114 / 1645337-2017-00113 / 1645337-2017-00112 are related to the same incident.
Event or Problem Description
It was reported by a customer that a shipment of mentor memory gel breast implants was received with damaged packaging, bugs inside the shipping box and black underneath the seal.Per the customer, the plastic wrapping the implant boxes was also damaged.The packaging appeared to have pinholes or bites, as well as black dots that could have been bug droppings.These implants did not make any contact with a patient, and the implants were sent back to mentor for replacement.Multiple attempts have been made to obtain more event details, however, no additional information has been made available.Since this event involves device sterility and could have led to an adverse event or serious injury, it is considered serious and mdr reportable.

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 6916337
• Report Number: 1645337-2017-00117
• Device Sequence Number: 12411289
• Product Code: FTR
• Combination Product (Y/N): N
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Type of Report: Initial
• Report Date (Section B): 09/05/2017

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 Catalogue Number: 350-5535BC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1