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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORP C-QUR TACSHIELD MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31633
Device Problem Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/08/2016
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted after the completion of the investigation into this event.
 
Event Description
During an open ventral hernia case there were two pieces of mesh in the sterile packet of a tacshield rather than one.
 
Manufacturer Narrative
Engineering analysis: engineering reviewed the sterilization and device history records for the product in question and review showed that criteria was met. Engineering summary: the picture provided by the hospital shows a "spare" piece of tacshield after implanting one of the devices. The spare part was discarded rather than sent back for evaluation, so engineering cannot confirm the tacshield in the picture was the one scrapped in process. A review of past product complaints by the complaints department show that we have not had a complaint for multiple parts in the same packaging. Given the controls in place, this is likely an isolated incident that was not identified during the 100% inspection visual inspection just prior to placing product in a handling sleeve in process. As far as the assessment of whether or not the parts were sterile, engineering is confident that the two pieces of c-qur tacshield cited in the complaint were not a worst case challenge when compared to the validations that had been performed. Based on the assessment detailed in the investigation and the results from those sterilization validations, the parts are sterile and should perform as intended. Clinical evaluation: if there is a compromise in the integrity of the packaging of a sterile device, it would be noticed prior to being introduced to the surgical site. This may create a delay in the procedure while a second device is located and prepped. The complaint states that two pieces of mesh were found inside the sterile packet instead of just one. In the event that an additional piece of the product was added to the package after receipt at the facility the sealed pouch and the seal on the outer box would be broken. The instructions for use warn, 'this device is supplied sterile. Please inspect packaging to ensure it is intact and not damaged prior to use. '.
 
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Brand NameC-QUR TACSHIELD
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORP
40 continental blvd.
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL CORP.
40 continental blvd.
merrimack NH 03054
Manufacturer Contact
theresa morin
10 bowman drive
hudson, NH 03051
6038645237
MDR Report Key6095395
MDR Text Key60091646
Report Number3011175548-2016-00009
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K100076
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/11/2019
Device Model Number31633
Device Catalogue Number31633
Device Lot Number408265
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 Received12/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/11/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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