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U.S. Department of Health and Human Services

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

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AROA BIOSURGERY LTD. OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH Back to Search Results
Model Number F10256-1020G
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Obstruction/Occlusion (2422); Bowel Perforation (2668)
Event Date 06/15/2022
Event Type  Injury  
Manufacturer Narrative
A small bowel obstruction has multiple potential causes and after discussion with the surgeon it cannot be determined whether the device caused or contributed to this event or other factors, such as surgical technique or suture material utilized, may have contributed to this event. No device problem was found from review of the dhr. The devices in ert-21d17 were produced as per established manufacturing procedures. All process specifications including package labelling requirements were met.
 
Event Description
It was reported that approximately 5 days after hernia repair with ovitex 1s resorbable that a patient experienced symptoms of a small bowel obstruction. Medical treatment alone was unsuccessful and the patient returned to surgery where the small bowel was resected. During surgery it was noted that the bowel was markedly adherent to the abdominal wall. A minute small bowel perforation was also noted.
 
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Brand NameOVITEX REINFORCED TISSUE MATRIX
Type of DeviceSURGICAL MESH
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 o'brien
2 kingsford smith place
airport oaks, auckland 2022
NZ   2022
MDR Report Key14982733
MDR Text Key295679326
Report Number3007321028-2022-00021
Device Sequence Number1
Product Code FTM
UDI-Device Identifier09421904065314
UDI-Public09421904065314
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153633
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation
Type of Report Initial
Report Date 07/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2022
Device Model NumberF10256-1020G
Device Catalogue NumberF10256-1020G
Device Lot NumberERT-21D17
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/30/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/11/2022 Patient Sequence Number: 1
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