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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 R20253-1018G
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Wound Dehiscence (1154); Necrosis (1971); Post Operative Wound Infection (2446)
Event Date 08/21/2019
Event Type  Injury  
Event Description
A patient underwent a unilateral (right) mastectomy, after which a 500cc expander was implanted. Before implantation, the pocket was irrigated with chlorpactin and the skinflap treated with betadyne. Two restella devices were sewn together with 3-0 monocryl, covering the expander and attached to its tabs. The expander tabs 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 wound dressing. On (b)(6) 2019, about a week after surgery, the skin flap had developed necrosis and became infected. As a result the expander and its restella cover were removed.
 
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Brand NameRESTELLA
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
AROA BIOSURGERY
2 kingsford smith place
airport oaks
auckland, 2022
NZ 2022
MDR Report Key8983935
MDR Text Key157341594
Report Number3010513348-2019-00004
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 08/26/2019,08/23/2019
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 Catalogue 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? No
Distributor Facility Aware Date08/21/2019
Device Age3 MO
Event Location Hospital
Date Report to Manufacturer08/26/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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