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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); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Cellulitis (1768); Diarrhea (1811); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Staphylococcus Aureus (2058); Sepsis (2067); Swelling (2091); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Ascites (2596)
Event Type  Injury  
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 a mini laparotomy excision of necrotic and the placement of a mesh due to drainage of abdominal wall abscess, repair of ventral incisional hernia. The patient underwent an additional implant approximately 1 year and 1 month post op. The patient underwent 2 revision surgeries in (b)(6) 2011 and (b)(6) 2011. The patient experienced pain, infection, iv drug therapy, and wound difficulty.
 
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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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key6884685
MDR Text Key87209083
Report Number9617613-2017-05115
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 10/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2012
Device Model NumberP101010
Device Catalogue NumberP101010
Device Lot Number09B2201
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/16/2009
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: 09/21/2017 Patient Sequence Number: 1
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