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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AROA BIOSURGERY LTD. OVITEX REINFORCED BIOSCAFFOLD; SURGICAL MESH
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AROA BIOSURGERY LTD. OVITEX REINFORCED BIOSCAFFOLD; SURGICAL MESH Back to Search Results
Device Problem Degraded (1153)
Patient Problem Hernia (2240)
Event Type  Injury  
Manufacturer Narrative
Lot number and product code information were not received, thus prohibiting manufacturing review.
 
Event Description
A surgeon simultaneously reported three cases in which an infection developed after hernia repair with ovitex (exact part number unknown).It was reported that in the presence of these infections, varying amounts of the device dissolved, leaving the polypropylene suture behind.The surgeon re-operated to remove portions of the implant and remaining polypropylene.In this case a portion of the polypropylene was adherent to the bowel, and its removal required a resection of a small piece of bowel.This is 1 of 3 such cases reported.
 
Manufacturer Narrative
Correct description of event: a surgeon simultaneously reported three cases in which an infection developed after hernia repair with ovitex (exact part number unknown).This is case 3 of 3 reported.It was reported that in the presence of these infections, varying amounts of the device dissolved, leaving the polypropylene suture behind.The surgeon re-operated to remove portions of the implant and remaining polypropylene.
 
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Brand Name
OVITEX REINFORCED BIOSCAFFOLD
Type of Device
SURGICAL MESH
Manufacturer (Section D)
AROA BIOSURGERY LTD.
2 kingsford smith place
airport oaks, auckland 2022
NZ  2022
MDR Report Key11234356
MDR Text Key228853859
Report Number3007321028-2020-00022
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K153632
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Date Manufacturer Received11/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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