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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION MESH PROLITE SHEETS MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1000606-00
Device Problem Off-Label Use (1494)
Patient Problems Nerve Damage (1979); Pain (1994); Swelling/ Edema (4577)
Event Type  Injury  
Event Description
This event is deemed reportable based on the allegations in a lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medical¿s mesh product. Plaintiff allegedly experienced chronic pain, inflammation, swelling, vaginal scarring, vaginal bleeding, constipation, organ perforation, severe nerve damage and revision surgery on (b)(6) 2020 with additional surgeries. Note: atrium¿s mesh was used off-label for pelvic organ prolapse and/or stress urinary inconvenience repair surgery. Since this is a legal matter, the case has been turned over to legal counsel and further information obtained through investigation or discovery may fall under the attorney/client and/or work product privilege. However, atrium will supplement this report as appropriate if additional information comes to its attention.
 
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 mesh passed all quality and performance requirement. This report is based upon allegations made in a lawsuit in which atrium medical is named as a defendant. This report shall not be considered as an admission by atrium medical that the product described in the lawsuit claim and described herein is or was defective, or that it had any causal relationship to any injuries allegedly suffered by the plaintiff.
 
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Brand NameMESH PROLITE SHEETS
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH
Manufacturer Contact
lori gosselin
40 continental blvd
merrimack, NH 
MDR Report Key14459757
MDR Text Key292219664
Report Number3011175548-2022-00144
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00650862300079
UDI-Public00650862300079
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K002093
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2017
Device Model Number1000606-00
Device Catalogue Number1000606-00
Device Lot Number10819798
Was Device Available for Evaluation? No
Date Manufacturer Received05/12/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/24/2012
Is the Device Single Use? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 05/20/2022 Patient Sequence Number: 1
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