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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION C-QUR MESH MESH, SURGICAL, POLYMERIC

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ATRIUM MEDICAL CORPORATION C-QUR MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Seroma (2069); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
 
Event Description
Article received: wang, e. E. (2021). Large abdominal hernia repair with closed incision negative pressure therapy: a case series. Journal of wound care, 192-196. Purpose: this study assesses the wound outcomes for hernia repair patients receiving closed incision negative pressure therapy (cinpt). Method: a six-year retrospective case series of patients who had undergone large abdominal incisional hernia repair wounds treated with cinpt was conducted. Conclusion: cinpt, when used after large abdominal incisional hernia repair, may help in the prevention of wound complications. Per the article adverse events included: surgical site infection, seroma, dehiscence and recurrence.
 
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Brand NameC-QUR MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH
Manufacturer Contact
dorota wolpiuk
40 continental blvd
merrimack, NH 
MDR Report Key12045604
MDR Text Key262400114
Report Number3011175548-2021-00692
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 company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/22/2021 Patient Sequence Number: 1
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