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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DSM BIOMEDICAL, INC. ARTHREX DX REINFORCED MATRIX SURGICAL MESH

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DSM BIOMEDICAL, INC. ARTHREX DX REINFORCED MATRIX SURGICAL MESH Back to Search Results
Model Number 30031-02
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Inflammation (1932)
Event Type  Injury  
Manufacturer Narrative
Review of device history files for final product lot 7002099 and intermediate material lots 8002159 (pn 6445-61) and e8176 (pn 6199-04) show no ncr that could cause failure mode. Device could not be returned. Root cause could not be determined and dhf review shows no ncr/deviation from process that could lead to failure mode.
 
Event Description
It was reported that the arthrex dx device (abs-30002) was implanted. After 6 weeks, a synovialitis developed in the patient. A revision surgery to an inverse prothesis was necessary.
 
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Brand NameARTHREX DX REINFORCED MATRIX
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DSM BIOMEDICAL, INC.
735 pennsylvania drive
exton PA 19341
Manufacturer (Section G)
DSM BIOMEDICAL, INC.
735 pennsylvania drive
exton PA 19341
Manufacturer Contact
alice cousens
735 pennsylvania drive
exton, PA 19341
MDR Report Key9240625
MDR Text Key167834196
Report Number2530154-2019-00007
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K091499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/01/2022
Device Model Number30031-02
Device Catalogue Number30031-02
Device Lot Number7002099
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/26/2019
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: 10/25/2019 Patient Sequence Number: 1
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