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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL PROLITE ULTRA MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 30717
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/13/2017
Event Type  malfunction  
Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
 
Event Description
Hospital reported that the doctor did the left femoral hernia operation in the morning of (b)(6) 2017. When he opened the outer packing of the product there was a little crack on the seal of the inner packing. He changed to another unit and no impact to patient.
 
Manufacturer Narrative
As the device in question was not returned it is difficult to determine the cause of the complaint. A review of the device history records was conducted to ensure the product was manufactured and inspected properly. The review of the device history records indicates that the product was manufactured and inspected properly. It is possible that the product was damaged during transit or after the package was opened in the field. This cannot be confirmed based on the information provided and without the physical product in question. Based on the details provided, atrium medical cannot conclude that the crack on the seal of the inner packaging was created or damaged at the site of manufacture without the physical sample. Clinical evaluation: a hernia occurs when tissue, such as part of the intestine, protrudes through a weak spot in the abdominal muscles. A hernia doesn't improve on its own, however, and can lead to serious complications. Surgery is recommended to repair a hernia that is painful or enlarging. Prolite ultra is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material. An inguinal (or femoral) hernia is when tissue or intestines protrude through a weakened area of tissue in the area on either side of the pubic bone. When a product is brought to the surgical arena and prepared for use it is inspected to insure the integrity of the packaging, the expiration dates and confirmation of the correct product size and type, etc. Is conducted between two clinicians in accordance with the safe practice recommendations provided by the joint commission. If any discrepancies are discovered the product is rejected and a new one is prepared. This may represent a delay prior to patient contact while the second product is prepared. When this step is omitted, and a product within a defective package is used it would put the patient at increased risk for infection. The instructions for use (ifu) states that this device is supplied sterile and to please inspect packaging to ensure it is intact and not damaged prior to use. Do not use if package is damaged or opened.
 
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Brand NamePROLITE ULTRA MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer Contact
40 continental blvd
merrimack, NH 03054
MDR Report Key7805561
MDR Text Key118102624
Report Number3011175548-2018-00915
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
K002093
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/30/2020
Device Model Number30717
Device Catalogue Number30717
Device Lot Number402049
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received09/04/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/04/2015
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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