MESH PROLOOP PLUGS 30902

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for MESH PROLOOP PLUGS 30902 manufactured by Atrium Medical Corporation.

Event Text Entries

[186093210] 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. Not returned.
Patient Sequence No: 1, Text Type: N, H10


[186093211] This event is deemed reportable based on the allegations in a potential lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of an atrium medical mesh product. Plaintiff allegedly experienced unspecified injuries and complications with multiple revisions as a result of the implantation of the mesh implant. Since this is a potential 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011175548-2020-00474
MDR Report Key9892287
Date Received2020-03-27
Date of Report2020-03-27
Date Mfgr Received2020-03-18
Device Manufacturer Date2010-05-03
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer Street40 CONTINENTAL BLVD
Manufacturer CityMERRIMACK NH 03054
Manufacturer CountryUS
Manufacturer Postal03054
Manufacturer G1ATRIUM MEDICAL CORPORATION
Manufacturer Street40 CONTINENTAL BLVD
Manufacturer CityMERRIMACK NH 03054
Manufacturer CountryUS
Manufacturer Postal Code03054
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMESH PROLOOP PLUGS
Generic NameMESH, SURGICAL, POLYMERIC
Product CodeFTL
Date Received2020-03-27
Model Number30902
Catalog Number30902
Lot Number10619964
Device Expiration Date2015-04-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerATRIUM MEDICAL CORPORATION
Manufacturer Address40 CONTINENTAL BLVD MERRIMACK NH 03054 US 03054


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-27

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