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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS; EXPANDER, SKIN, INFLATABLE
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MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS; EXPANDER, SKIN, INFLATABLE Back to Search Results
Model Number 3549314
Medical Device Problem Codes Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Code Deformity/ Disfigurement (2360)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: tissue expander deflation.Manufacturer¿s reference number: (b)(4).
 
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Brand Name
MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS
Common Device Name
EXPANDER, SKIN, INFLATABLE
MDR Report Key12716467
Report Number1645337-2021-12055
Device Sequence Number3856002
Product Code LCJ
UDI-Device Identifier00081317006800
UDI-Public00081317006800
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K130813
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number3549314
Device Catalogue Number3549314
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/07/2021
Initial Report FDA Received Date10/28/2021
Was Device Evaluated by Manufacturer? (Y/N) No
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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