• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC BREAST IMPLANT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MENTOR WORLDWIDE LLC BREAST IMPLANT Back to Search Results
Catalog Number 350-1490
Device Problem Component Missing
Event Date 01/27/2017
Event Type  Injury  
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. (b)(4). The device was not received by mentor yet.

 
Event Description

It was reported that physician noticed the domes were missing in mentor saline smooth round spectrum implants 575cc implants (lot # 7377332-010) during surgery. By that time the patient was on the table. Physician opened another set of implants (lot # 7377332-033) however it was missing domes as well. Additional information was obtained: the procedure was not canceled as the physician continued the procedure. However the delay caused a potential risk to the patient. The event required surgical intervention as the physician used a venous ports seal kit on the patient. Patient was required extended hospitalization. Patient was under general anesthesia for 4 hours (from 7:46am to 12:06pm). The patient is fine now. No other information was available about the patient. Device was sent back to mentor.

 
Manufacturer Narrative

On march 27, 2017, mentor worldwide llc has initiated a voluntary remedial action to remove one (1) lot of mentor® saline-filled spectrum¿ breast implants (575cc) lot number 7377332. Some units in the affected lot do not contain the dome pack accessory indicated on the box label. (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
MENTOR WORLDWIDE LLC
33 technology drive
irvine CA 92618
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 Key6350753
Report Number1645337-2017-00012
Device Sequence Number1
Product CodeFWM
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 01/27/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/22/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number350-1490
Device LOT Number7377332-010
OTHER Device ID Number350-1490
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
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

Patient TREATMENT DATA
Date Received: 02/22/2017 Patient Sequence Number: 1
-
-