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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

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MENTOR WORLDWIDE LLC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED Back to Search Results
Catalog Number 3545455
Device Problem Device Contamination with Chemical or Other Material
Event Date 11/18/2016
Event Type  Malfunction  
Manufacturer Narrative

The product investigation has begun but it has not been completed at this time. When the investigational analysis has been completed, a supplemental 3500a report will be submitted. The device history record (dhr) of lot number 7374907 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).

 
Event Description

It was reported that memorygel siltex round ultra high 455c (p/n: 3545455; l/n: 7374907-027) had a piece of fiber on it and it did not appear sterile.

 
Manufacturer Narrative

Device evaluation results: it was reported that memorygel siltex round ultra high 455c (p/n: 3545455; l/n: 7374907-027) had a piece of fiber on it and it did not appear sterile. Upon receipt at mentor, the device contained clear fluid and weighed 462. 7 grams. No foreign material was observed within the device, nor on the shell surface. The device was found to be intact. No anomalies were observed. Mentor performs 100% inspection and testing of all devices prior to release, including inspections for surface imperfections and foreign materials in/on the shell. The customer complaint could not be confirmed. Manufacturer¿s ref. No: (b)(4). Legacy manufacturer's ref. (b)(4).

 
Event Description

It was reported that memorygel siltex round ultra high 455c (p/n: 3545455; l/n: 7374907-027) had a piece of fiber on it and it did not appear sterile.

 
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Brand NameMENTOR MEMORYGEL BREAST IMPLANT
Type of DevicePROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
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 Key6810708
Report Number1645337-2017-00057
Device Sequence Number1
Product CodeFTR
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/18/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/22/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number3545455
Device LOT Number7374907
OTHER Device ID Number3545455
Was Device Available For Evaluation? Yes
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? Yes
Date Device Manufactured09/15/2016
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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