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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 Wound Dehiscence (1154)
Event Date 11/05/2019
Event Type  Injury  
Event Description
A patient with an approximately 10-year old subpectoral breast reconstruction underwent a bilateral subpectoral to prepectoral conversion on (b)(6) 2019.The implants were anteriorly covered with restella resorbable (pga).The patient returned on (b)(6) 2019 (55 days post op) with breakdown of the 10-year old incision above the nipple of the left breast.As a precaution, the surgeon removed both breast implants and any unincorporated portions of the restella resorbable.
 
Event Description
See initial mdr report.
 
Manufacturer Narrative
The patient's age was corrected to 51 years.The date of birth as listed in the original mdr report is correct.
 
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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 Key9413523
MDR Text Key169457997
Report Number3010513348-2019-00009
Device Sequence Number1
Product Code FTM
UDI-Device Identifier09421905067034
UDI-Public09421905067034
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
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 Date04/30/2020
Device Catalogue NumberR20153-2020G
Device Lot NumberERT-9E02
Was Device Available for Evaluation? No
Distributor Facility Aware Date11/06/2019
Device Age6 MO
Event Location Hospital
Date Report to Manufacturer11/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age51 YR
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