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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT

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MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT Back to Search Results
Catalog Number 350-5535BC
Device Problems Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping
Event Date 01/05/2017
Event Type  Malfunction  
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 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.

 
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Brand NameMENTOR MEMORYGEL BREAST IMPLANT
Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
MENTOR TEXAS
3041 skyway circle north
irving TX 75038
Manufacturer (Section G)
MENTOR TEXAS
3041 skyway circle north
irving TX 75038
Manufacturer Contact
joaquin kurz
3041 skyway circle north
irving , TX 75038
949789-383
MDR Report Key6916337
Report Number1645337-2017-00117
Device Sequence Number1
Product CodeFTR
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 09/05/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/05/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number350-5535BC
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2017
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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