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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STYLE 133PLUS MX TISSUE EXPANDER WITH SUTURE TAB; EXPANDER, SKIN, INFLATABLE
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STYLE 133PLUS MX TISSUE EXPANDER WITH SUTURE TAB; EXPANDER, SKIN, INFLATABLE Back to Search Results
Catalog Number 133P-MX-14-T
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.The event of infection (early onset) is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: infection (early onset).This is a known potential adverse event addressed in the product labeling.
 
Event or Problem Description
Health professional reported left side infection.Device was explanted and discarded.
 
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Brand Name
STYLE 133PLUS MX TISSUE EXPANDER WITH SUTURE TAB
Common Device Name
EXPANDER, SKIN, INFLATABLE
MDR Report Key8844978
Report Number9617229-2019-09882
Device Sequence Number253655
Product Code LCJ
UDI-Device Identifier10888628010192
UDI-Public10888628010192
Combination Product (Y/N)N
PMA/510(K) Number
K143354
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/31/2019
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? No
Operator of Device Health Professional
Device Expiration Date10/14/2021
Device Catalogue Number133P-MX-14-T
Device Lot Number2985016
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/02/2019
Initial Report FDA Received Date07/31/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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