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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES MESH TSL - PERMACOL¿; MESH, SURGICAL

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TISSUE SCIENCE LABORATORIES MESH TSL - PERMACOL¿; MESH, SURGICAL Back to Search Results
Model Number P101010
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pain (1994); Injury (2348); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient underwent incisional hernia repair with mesh.The patient had revision surgery 2 years and 1 months post surgery.The patient experienced infection, chronic pain, hernia recurrence, intestinal blockage.
 
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Brand Name
MESH TSL - PERMACOL¿
Type of Device
MESH, SURGICAL
Manufacturer (Section D)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB  GU11 1EJ
Manufacturer (Section G)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB   GU11 1EJ
Manufacturer Contact
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key7122723
MDR Text Key95013914
Report Number9617613-2017-05154
Device Sequence Number1
Product Code FTM
UDI-Device Identifier10884523000108
UDI-Public10884523000108
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial
Report Date 12/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2014
Device Model NumberP101010
Device Catalogue NumberP101010
Device Lot Number11B0109
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/20/2017
Initial Date FDA Received12/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age41 YR
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