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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL MESH, SURGICAL, POLYMERIC

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ATRIUM MEDICAL MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Peeled/Delaminated (1454)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event.
 
Event Description
Surgeon report that the coating peeled off during handling. Additionally, c-qur was difficult to fix to abdominal wall by absorbatack.
 
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Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer Contact
40 continental blvd
merrimack, NH 03054
MDR Report Key7586467
MDR Text Key111079810
Report Number3011175548-2018-00575
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 06/11/2018 Patient Sequence Number: 1
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