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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC BREAST IMPLANT

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MENTOR WORLDWIDE LLC BREAST IMPLANT Back to Search Results
Catalog Number 3502350
Device Problem Component Missing
Event Date 11/17/2016
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) of lot number 7381657 was reviewed and no anomalies were found related to this complaint. In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures. (b)(4). Device was not returned to mentor.

 
Event Description

It was reported that fill tube and check valve were missing from box of implant (b)(4) (p/n: 3502350; l/n: 7381657-018). It stated that the implant did come in contact with patient. The patient information was not available. It was further reported that the surgeon used fill tube from secondary implant that was used for contralateral side. The customer kept the product. No additional information has been received to date. If additional information is received, a supplemental 3500a report will be submitted.

 
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Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
MENTOR WORLDWIDE LLC
3041 skyway circle
north irving TX 75038 3540
Manufacturer (Section G)
MENTOR WORLDWIDE LLC
3041 skyway circle
north irving TX 75038 3540
Manufacturer Contact
joaquin kurz
north irving , TX 75038-3540
9497893837
MDR Report Key6821798
Report Number1645337-2017-00067
Device Sequence Number1
Product CodeFWM
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 11/18/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/25/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number3502350
Device LOT Number7381657-018
OTHER Device ID Number3502350
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/18/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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