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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 Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); Material Deformation (2976); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Hematoma (1884); Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Seroma (2069); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Abdominal Distention (2601); No Code Available (3191); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
Additional information: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Manufacturer reference number: (b)(4). A good faith effort will be made to obtain the applicable information relevant to the report. 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 has had hernia reoccurrence, adhesions, intestinal blockage, revision surgery, surgery to remove mesh, an open wound that won¿t heal, and chronic abdominal pain.
 
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Brand NameMESH TSL - PERMACOL¿
Type of DeviceMESH, 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
justin ellis
60 middletown avenue
8200 coral sea st ne
mounds view,mn, CT 55112
7635265677
MDR Report Key6898479
MDR Text Key248325840
Report Number9617613-2017-05119
Device Sequence Number1
Product Code FTM
UDI-Device Identifier10884523000108
UDI-Public10884523000108
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992556
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2014
Device Model NumberP101010
Device Catalogue NumberP101010
Device Lot Number10B2302
Was Device Available for Evaluation? No
Date Manufacturer Received10/05/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/17/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/27/2017 Patient Sequence Number: 1
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