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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR TACSHIELD MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31633
Event Date 03/21/2016
Event Type  Injury  
Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

 
Event Description

It was reported by a surgeon that his patient had a skin reaction after implant of a surgical mesh. The reaction was noted on the patient's posterior and was considered to be caused by the hospital bedding and equipment. Eight months post procedure the patient returned to the physician's office with a rash that he thought was at the edge of the implanted mesh. A ct scan revealed no apparent fluid accumulation and the mesh was well incorporated with no signs of bowel injury. Patient treated with steroid cream.

 
Manufacturer Narrative

A review of lot history and sterilization records was performed. The finished good and subassembly lots passed all in-process inspections and testing including but not limited to fourier transform infrared spectroscopy and seal strength on pre and post sterile pouches. All raw materials met all incoming testing and inspections. Review shows that this lot met all sterilization and manufacturing acceptance criteria for lot release. Clinical evaluation: clinical evaluation: a rash is a noticeable change in the texture or color of the skin. The skin may become scaly, bumpy, itchy, or otherwise irritated. There are numerous causes for rashes, including: exposure to an irritant or another foreign substance. Possible irritants could be laundry detergent, personal hygiene products, chemicals or poisonous plants. The resulting rash may be itchy and red or inflamed. A rash may also indicate infection. Microorganisms can infect a surgical wound through various forms of contact, such as from the touch of a contaminated caregiver or surgical instrument, through microorganisms in the air or in your body. Any infection will cause redness, delayed healing, fever, pain, tenderness, warmth, or swelling. Other risks for infection include a compromised patient, elderly and/or overweight patients, weakened immune systems and diabetes. Most surgical site infections can be treated successfully with antibiotic medications. It states in adverse reactions, "complications that may occur with the use of any surgical mesh include, but are not limited to inflammation and infection.

 
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Brand NameC-QUR TACSHIELD MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
5 wentworth drive
hudson NH
Manufacturer Contact
theresa morin
40 continental blvd
merrimack , NH 03054
6038645237
MDR Report Key5555054
Report Number1219977-2016-00060
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/22/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/07/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date05/31/2017
Device MODEL Number31633
Device Catalogue Number31633
Device LOT Number207844
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 Received04/15/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/10/2014
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: 04/07/2016 Patient Sequence Number: 1
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