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U.S. Department of Health and Human Services

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

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AROA BIOSURGERY LTD. RESTELLA MESH, SURGICAL Back to Search Results
Model Number R20253-1018G
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Wound Dehiscence (1154); Necrosis (1971); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
Dhr review: restella resorbable polymer batch ert-9e01 was fabricated on 01 may 2019. The completed batch record was reviewed to assist this investigation. Forty-four devices were manufactured and released for sale. Qc release testing for the final batches were reviewed. All tests were carried out as per established testing procedures, the individual results from the required test were all within aroa's specification. Batch was approved to release based on the completion of correct manufacturing processes and satisfactory results of the quality testing on the final devices. This batch was released for commercial sale from may 2019. There are no other device complaints received from any other customers for this batch. Based on the investigation, there is no evidence showing a suspected association between the patient developing skin necrosis and infection and the use of the device from this restella batch.
 
Event Description
A patient underwent a unilateral (right) mastectomy, after which a 500cc allergan expander was implanted. Before implantation, the pocket was irrigated with chlorpactin and the skinflap treated with betadyne. Two restella 10x18. 5cm resorbable contours were sewn together with 3-0 monocryl and attached to the expander tabs. The expander tabs and some of the restella were attached to the chest wall. A blake drain was placed medially and along the imf and the skin flap closed. The incision was covered with gauze and tegraderm. On (b)(6) 2019 the expander and restella were removed due to dehiscence/exposure. There was noted skin necrosis and infection.
 
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Brand NameRESTELLA
Type of DeviceMESH, SURGICAL
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 Key8984595
MDR Text Key159678034
Report Number3007321028-2019-00014
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 09/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2020
Device Model NumberR20253-1018G
Device Lot NumberERT-9E01
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 Received08/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/10/2019 Patient Sequence Number: 1
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