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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORP C-QUR V-PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31200
Device Problem Device Packaging Compromised (2916)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/08/2016
Event Type  malfunction  
Manufacturer Narrative
Upon the completion of the investigation into this event a follow up report will be submitted.
 
Event Description
Received a report that when the package was opened, the clear sterile wrapper was caught in the seam of the foil wrapper. Device was not used.
 
Manufacturer Narrative
The complaint contends that the handling sleeve which the product sits in was caught in the seal. It is presumed to be the environmental seal that atrium places as the pouches come sealed on 3 sides from the vendor. Once the product is inserted in the pouch, a final environmental seal is placed at the top of the pouch. The complaint contends that the sleeve was caught in this seal. The hospital was concerned about the sterility of the product was in question so they discarded the part and packaging deciding not to use it. For this investigation, the packaging and product is not available to be analyzed. In reviewing the device history record (dhr) of the lot in question, the scrap collection work sheet lists 2 parts being scrapped for "incorrect placement of mesh in the pouch". This scrap description is usually reserved for when the handling sleeve appears to be in the sealing area of the environmental seal. The hospital complaint did detail that happening. The fact that manufacturing has rejects for this detailed on the dhr shows that they can inspect this out of the manufacturing process. However, without the actual product and packaging, engineering can't confirm this incident that the hospital in fact got a package with a handling sleeve stuck in the seal. Clinical evaluation: microorganisms can enter a surgical wound through various forms of contact, such as from the caregiver or surgical instrument and devices, or through microorganisms in the air. The instructions for use state that this device is supplied sterile and also states the method of sterilization. Infection is a risk associated with any type of surgery and should be considered as part of the education and informed consent decision that occurs between the patient and their physician prior to any surgery. The packaging must be inspected prior to use to ensure it is intact and not compromised in any way.
 
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Brand NameC-QUR V-PATCH
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
40 continental blvd
merrimack, NH 03054
6038645237
MDR Report Key5885238
MDR Text Key52385081
Report Number3011175548-2016-00005
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090909
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/02/2019
Device Model Number31200
Device Catalogue Number31200
Device Lot Number404916
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 Received09/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/02/2016
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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