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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 08/22/2019
Event Type  Injury  
Event Description
A patient who had undergone a bilateral mastectomy due to breast cancer underwent a prepectoral breast reconstruction with tissue expanders and restella resorbable (pga) on (b)(6) 2019.The expanders were anteriorly covered with restella resorbable.The patient's left expander deflated and she was brought back for re-operation on (b)(6) 2019 (42 days post-op) to replace the expander.At the time of reoperation, it was noted that the restella resorbable was still in the process of incorporating.As a precaution, the surgeon removed some unincorporated portions of the restella resorbable device.
 
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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 Key9413537
MDR Text Key169260462
Report Number3010513348-2019-00008
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
Date FDA Received12/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/29/2020
Device Catalogue NumberR20153-2020G
Device Lot NumberERT-9C03
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
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 Age52 YR
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