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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR TEXAS SMOOTH ROUND SPECTRUM® BREAST IMPLANT

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MENTOR TEXAS SMOOTH ROUND SPECTRUM® BREAST IMPLANT Back to Search Results
Catalog Number 3501440
Device Problem Component Missing
Event Date 08/16/2017
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. The device history record (dhr) review is in progress. Once completed, the information will be submitted in a supplemental. (b)(4).

 
Event Description

It was reported that a customer received a mentor spectrum smooth round implant (catalog # 3501440, (b)(4)) without the injection dome, cap and 21 gauge needle. No patient consequence was reported. They opened another implant for the missing items and procedure was completed.

 
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Brand NameSMOOTH ROUND SPECTRUM® BREAST IMPLANT
Type of DeviceSMOOTH ROUND SPECTRUM® BREAST IMPLANT
Manufacturer (Section D)
MENTOR TEXAS
3041 skyway circle north
irving 75038
Manufacturer Contact
joaquin kurz
3041 skyway circle north
irving , TX 75038
949789-383
MDR Report Key6866929
Report Number1645337-2017-00107
Device Sequence Number1
Product CodeFWM
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 08/16/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/14/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number3501440
Device LOT Number7411747
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 Received08/16/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/19/2016
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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