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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AROA BIOSURGERY LTD. RESTELLA SURGICAL MESH

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AROA BIOSURGERY LTD. RESTELLA SURGICAL MESH Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Erythema (1840); Seroma (2069)
Event Type  Injury  
Manufacturer Narrative
Further attempts will be made to obtain additional information.
 
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 LTD.
2 kingsford smith place
airport oaks, auckland 2022
NZ 2022
Manufacturer (Section G)
AROA BIOSURGERY LTD.
2 kingsford smith place
airport oaks, auckland 2022
NZ 2022
Manufacturer Contact
tina obrien
2 kingsford smith place
airport oaks, auckland 2022
NZ   2022
MDR Report Key9614187
MDR Text Key176943145
Report Number3007321028-2020-00001
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183398
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 01/22/2020
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?
Event Location No Information
Date Manufacturer Received01/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/21/2020 Patient Sequence Number: 1
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