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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 Seroma (2069)
Event Date 11/04/2019
Event Type  Injury  
Event Description
A patient underwent a bilateral mastectomy with immediate direct to implant prepectoral breast reconstruction on (b)(6) 2019.The breast implants were anteriorly covered with restella resorbable (pga).The patient exhibited drainage of opaque fluid on both sides.Swelling and redness developed, first on the right breast on (b)(6) 2019 (32 days post op) on the lower pole.As a precaution the patient was taken to the or and the right breast implant and restella resorbable were removed.Three days later the surgeon noticed a similar pattern on the left breast.The patient returned to the or that day and the left breast implant and restella resorbable were removed.
 
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Brand Name
RESTELLA
Type of Device
SURGICAL MESH
Manufacturer (Section D)
AROA BIOSURGERY
2 kingsford smith place
airport oaks
auckland, 2022
NZ  2022
MDR Report Key9413524
MDR Text Key169459864
Report Number3010513348-2019-00012
Device Sequence Number1
Product Code FTM
UDI-Device Identifier09421905067034
UDI-Public09421905067034
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Physician
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/30/2020
Device Catalogue NumberR20153-2020G
Device Lot NumberERT-9E02
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
Device Age5 MO
Event Location Hospital
Date Report to Manufacturer11/14/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age35 YR
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