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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AROA BIOSURGERY OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH

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AROA BIOSURGERY OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH Back to Search Results
Model Number F10248-1020P
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Obstruction/Occlusion (2422)
Event Date 07/14/2022
Event Type  Injury  
Manufacturer Narrative
Intraperitoneal placement of surgical mesh carries a known risk of adhesions. Such adhesions, whether device or surgery related, may lead to small bowel obstruction. It cannot be definitively determined whether the device contributed to this event.
 
Event Description
A small bowel obstruction was reported after the use of ovitex 2s permanent in open ipom sugarbaker parastomal hernia repair. This required reoperation at which time there were noted loops of small bowel attached to the device and to the colon on the opposite side. The surgeon took down adhesions and corrected tears as necessary.
 
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Brand NameOVITEX REINFORCED TISSUE MATRIX
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
AROA BIOSURGERY
2 kingsford smith place
airport oaks, auckland 2022
NZ 2022
MDR Report Key15266190
MDR Text Key298313162
Report Number3010513348-2022-00005
Device Sequence Number1
Product Code FTM
UDI-Device Identifier09421904065178
UDI-Public09421904065178
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 08/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberF10248-1020P
Device Catalogue NumberF10248-1020P
Device Lot NumberERT-21F12
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/22/2022
Distributor Facility Aware Date07/29/2022
Event Location Hospital
Date Report to Manufacturer08/02/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/22/2022 Patient Sequence Number: 1
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