Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AROA BIOSURGERY LTD. OVITEX REINFORCED BIOSCAFFOLD; SURGICAL MESH
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AROA BIOSURGERY LTD. OVITEX REINFORCED BIOSCAFFOLD; SURGICAL MESH Back to Search Results
Model Number F10244-1020P
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Pain (1994)
Date of Event 06/04/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No device problem was found from review of the dhr.The devices in ert-8f03 were produced as per established manufacturing procedures.All process specifications were met.
 
Event or Problem Description
It was reported that a patient experienced a potential "reaction" to an ovitex p mesh implanted on (b)(6) 2019.It was removed on (b)(6) 2020.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OVITEX REINFORCED BIOSCAFFOLD
Common Device Name
SURGICAL MESH
Manufacturer (Section D)
AROA BIOSURGERY LTD.
2 kingsford smith place
airport oaks, auckland 2022
NZ  2022
MDR Report Key10192611
Report Number3007321028-2020-00008
Device Sequence Number16370797
Product Code FTM
UDI-Device Identifier09421904065031
UDI-Public09421904065031
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K153632
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date05/31/2020
Device Model NumberF10244-1020P
Device Catalogue NumberF10244-1020P
Device Lot NumberERT-8F03
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/12/2020
Initial Report FDA Received Date06/24/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
Patient Age48 YR
Patient Weight60
-
-