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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IDEAL IMPLANT IDEAL IMPLANT STRUCTURED BREAST IMPLANT; SALINE-FILLED BREAST IMPLANT

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IDEAL IMPLANT IDEAL IMPLANT STRUCTURED BREAST IMPLANT; SALINE-FILLED BREAST IMPLANT Back to Search Results
Model Number 40501
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/10/2017
Event Type  malfunction  
Event Description
Inadequate valve strap bond.
 
Manufacturer Narrative
The evaluation summary is as follows: macroscopic and microscopic examination of the explanted device revealed inadequate anterior valve strap bond to the implant shell.Device was not implanted.
 
Event Description
Deflation resulting in explantation.
 
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Brand Name
IDEAL IMPLANT STRUCTURED BREAST IMPLANT
Type of Device
SALINE-FILLED BREAST IMPLANT
Manufacturer (Section D)
IDEAL IMPLANT
14881 quorum drive
suite 925
dallas TX 75254
Manufacturer (Section G)
SPECIALTY SILICONE FABRICATORS, INC.
2761 walnut avenue
tustin CA 92780
Manufacturer Contact
stacey brown
14881 quorum drive
suite 925
dallas, TX 75254
2144922500
MDR Report Key6323773
MDR Text Key67383164
Report Number3011491947-2017-00006
Device Sequence Number1
Product Code FWM
UDI-Device Identifier10851795006060
UDI-Public(01)10851795006060(241)40501(17)180601
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/01/2018
Device Model Number40501
Device Catalogue Number405
Device Lot Number61193
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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