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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
Device Problem Insufficient Information (3190)
Patient Problems Erythema (1840); Seroma (2069)
Event Type  Injury  
Event Description
Approximately 10 weeks after implant based breast reconstruction, a patient presented with redness and some fluid build up. The right incision began to open up and it was decided to remove both expanders and the not yet incorporated portions of the restella device to better progress with treatment. During removal there was sterile exudate noted on both sides.
 
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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 Key9613156
MDR Text Key176273911
Report Number3010513348-2020-00001
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 01/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/21/2020
Distributor Facility Aware Date12/09/2019
Event Location Hospital
Date Report to Manufacturer01/17/2020
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: 01/21/2020 Patient Sequence Number: 1
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