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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 3504001BC
Medical Device Problem Code Shipping Damage or Problem (1570)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 04/10/2017
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.The device history record (dhr) of lot number 7402435 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).The product was not returned to mentor.
 
Event or Problem Description
It was reported that packaging for implant sm mpp gel 400cc (p/n: 3504001bc; l/n: 7402435-060) had hole in it.There was no patient contact reported.The procedure was completed with different device.It is unknown where and how the issue occurred.
 
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Common Device Name
BREAST IMPLANT
Manufacturer (Section D)
MENTOR WORLDWIDE LLC
3041 skyway circle
north irving TX 75038 3540
MDR Report Key6818545
Report Number1645337-2017-00061
Device Sequence Number86606
Product Code FTR
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Type of Report Initial
Report Date (Section B) 04/13/2017
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 Number3504001BC
Device Lot Number7402435-060
Other Device ID Number3504001BC
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/13/2017
Initial Report FDA Received Date08/24/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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