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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 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. No device problem was found from review of the dhr. The devices in ert-21f12 were produced as per established manufacturing procedures. All process specifications including package labelling requirements were met. Ckage labelling requirements were met.
 
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 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 Key15299217
MDR Text Key298662539
Report Number3007321028-2022-00030
Device Sequence Number1
Product Code FTM
UDI-Device Identifier09421904065178
UDI-Public09421904065178
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153632
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 08/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2022
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
Date Manufacturer Received08/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2021
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: 08/25/2022 Patient Sequence Number: 1
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