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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 Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/10/2017
Event Type  malfunction  
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.
 
Event Description
Inadequate valve strap bond.
 
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Brand NameIDEAL IMPLANT STRUCTURED BREAST IMPLANT
Type of DeviceSALINE-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 Key261539594
Report Number3011491947-2017-00006
Device Sequence Number1
Product Code FWM
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
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
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
Was the Report Sent to FDA?
Event Location No Information
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 Treatment Data
Date Received: 02/10/2017 Patient Sequence Number: 1
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