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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AROA BIOSURGERY OVITEX REINFORCED BIOSCAFFOLD SURGICAL MESH

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AROA BIOSURGERY OVITEX REINFORCED BIOSCAFFOLD SURGICAL MESH Back to Search Results
Catalog Number F10248-1822P
Device Problem Insufficient Information (3190)
Patient Problem Abscess (1690)
Event Date 05/15/2019
Event Type  Injury  
Manufacturer Narrative
Despite repeated requests, no further details on the cause, location, or content of the abscess were obtained, nor any further information regarding the findings during the second surgery. Absent further information, no conclusions can be drawn. Based on documented experience with post-operative infections it is unlikely that the abscess caused the partial digestion of the implant. A dhr review was completed and no non-conformances or anomalies were found that may have caused or contributed to the event. (b)(4).
 
Event Description
A ventral hernia repair was performed with ovitex 2s p on (b)(6) 2019. It was reported that the patient developed an abscess a few weeks after surgery which did not resolve with percutaneous drains. The patient underwent a second surgery on approximately (b)(6) 2019 in which the implant was found partially digested. The surgeon removed the implant.
 
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Brand NameOVITEX REINFORCED BIOSCAFFOLD
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
AROA BIOSURGERY
2 kingsford smith place
airport oaks
auckland, 2022
NZ 2022
Manufacturer (Section G)
AROA BIOSURGERY
2 kingsford smith place
airport oaks
auckland, 2022
NZ 2022
Manufacturer Contact
john urtz
1 great valley parkway
suite 24
malvern, PA 19355
4843202884
MDR Report Key8683048
MDR Text Key147470213
Report Number3007321028-2019-00006
Device Sequence Number1
Product Code FTM
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
Reporter Occupation
Type of Report Initial
Report Date 05/17/2019,06/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Catalogue NumberF10248-1822P
Device Lot NumberERT-8A07
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date05/17/2019
Device Age16 MO
Event Location Hospital
Date Report to Manufacturer05/17/2019
Date Manufacturer Received05/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/18/2018
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: 06/10/2019 Patient Sequence Number: 1
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