PERMACOL P101010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-06 for PERMACOL P101010 manufactured by Tissue Science Laboratories.

Event Text Entries

[187252896] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[187252897] The patient? S attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a hiatal hernia. It was reported that after implant, the patient experienced mesh "folded over the anterior esophagus," mesh migration and scarring. Post-operative patient treatment included two removal surgeries.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9617613-2020-00038
MDR Report Key9800102
Report SourceCONSUMER
Date Received2020-03-06
Date of Report2020-03-06
Date Mfgr Received2020-02-19
Date Added to Maude2020-03-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLISA HERNANDEZ
Manufacturer Street60 MIDDLETOWN AVE
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925563
Manufacturer G1TISSUE SCIENCE LABORATORIES
Manufacturer StreetVICTORIA HOUSE, VICTORIA ROAD
Manufacturer CityALDERSHOT, HAMPSHIRE GU111EJ
Manufacturer CountryGB
Manufacturer Postal CodeGU11 1EJ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePERMACOL
Generic NameMESH, SURGICAL
Product CodeFTM
Date Received2020-03-06
Model NumberP101010
Catalog NumberP101010
Lot Number09B0808
Device Expiration Date2012-07-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerTISSUE SCIENCE LABORATORIES
Manufacturer AddressVICTORIA HOUSE, VICTORIA ROAD ALDERSHOT, HAMPSHIRE GU111EJ GB GU11 1EJ


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-06

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