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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AROA BIOSURGERY RESTELLA SURGICAL MESH

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AROA BIOSURGERY RESTELLA SURGICAL MESH Back to Search Results
Catalog Number R20153-2020G
Device Problem Insufficient Information (3190)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 11/04/2019
Event Type  Injury  
Event Description
A patient underwent a bilateral mastectomy with immediate prepectoral tissue expander reconstruction on (b)(6) 2019. The expanders were anteriorly covered with restella resorbable (pga). The patient presented with an infected (s. Lugdunesis) seroma in the left breast and the left expander and restella resorbable were removed on (b)(6) 2019 (39 days post op). The right side remained intact.
 
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Brand NameRESTELLA
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
AROA BIOSURGERY
2 kingsford smith place
airport oaks
auckland, 2022
NZ 2022
MDR Report Key9413521
MDR Text Key179611357
Report Number3010513348-2019-00011
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 11/14/2019,12/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberR20153-2020G
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date11/06/2019
Event Location Hospital
Date Report to Manufacturer11/14/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/04/2019 Patient Sequence Number: 1
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