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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION PROLITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1000606-00
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 08/19/2010
Event Type  Injury  
Manufacturer Narrative
Investigation: based on the review of the device history records and product complaint details atrium can find no fault with the product. This lot of v-patch mesh passed all quality and performance requirement. The sterility records indicate that the lot in question was properly sterilized. Clinical evaluation: an inguinal hernia occurs when tissue, such as part of the intestine, protrudes through a weak spot in the lower abdominal muscles. The resulting bulge can be painful, especially when you cough, bend over or lift a heavy object. An inguinal hernia doesn't improve on its own, however, and can lead to life-threatening complications. Surgery is recommended to repair an inguinal hernia that's painful or enlarging. Prolite mesh is intended for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a non-absorbable supportive material. Gastrointestinal bloating and pain can occur after any type of surgery, but is most common after abdominal and pelvic surgery. Both open surgery and laparoscopic surgery in the abdominal cavity can leave the bowels (intestines) stunned'. Anesthesia can slow down the bowels, preventing the passage of gas and stool. Intraperitoneal bloating is caused by gas trapped outside of the intestines, but inside the abdominal cavity. The gas that becomes trapped in abdominal cavity or against the diaphragm muscle itself usually follows laparoscopic surgery. Prolonged pain can be defined as pain persisting for more than three months after surgery and it is a complication of many common procedures including hernia repair. Surgical technique can influence the development of chronic post-surgical pain and techniques to minimize nerve injury should be used whenever possible. The instructions for use state, "complications that may occur with the use of any surgical mesh include, but are not limited to, pain, inflammation, infection, seroma, hematoma, fistula formation or mechanical disruption of the tissue and/or mesh material, possible adhesions when placed in direct contact with the viscera (intestines) and organs. " the fixation technique, method, and products used are left to the discretion of the surgeon to optimize clinical outcomes. Careful attention to proper fixation techniques and placement of the mesh product should be taken to help prevent excessive tension or disruption between the mesh material and connective tissue. Placing surgical mesh in contact with the intestines and/or improper surgical fixation can increase incidence of adhesions and pain. The ifu also states that it is important to orient the mesh correctly for proper function. The smooth side of the mesh should be positioned facing the bowel or other visceral surfaces where minimal tissue attachment is desired. The anterior side to which the positioning straps are attached should be placed uniformly against the parietal tissue where tissue in-growth and incorporation is desired.
 
Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event.
 
Event Description
A patient reported having a lower left abdominal hernia repair. A couple of weeks after the surgery he had problems with stomach bloating and pain.
 
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Brand NamePROLITE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH 03051
Manufacturer (Section G)
ATRIUM MEDICAL CORP.
40 continental blvd.
5 wentworth drive
merrimack NH 03054
Manufacturer Contact
theresa morin
40 continental blvd.
merrimack, NH 03054
6038645237
MDR Report Key6633315
MDR Text Key114567869
Report Number1219977-2017-00091
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00650862300079
UDI-Public00650862300079
Combination Product (y/n)N
PMA/PMN Number
K0930669
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup
Report Date 06/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2015
Device Model Number1000606-00
Device Catalogue Number1000606-00
Device Lot Number10624883
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/22/2010
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: 06/12/2017 Patient Sequence Number: 1
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