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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES PERMACOL MESH, SURGICAL

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TISSUE SCIENCE LABORATORIES PERMACOL MESH, SURGICAL Back to Search Results
Model Number P101015
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Chest Pain (1776); Emotional Changes (1831); Hematoma (1884); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Seroma (2069); Swelling (2091); Dizziness (2194); Discharge (2225); Injury (2348); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: tem1208gl progrip lt tem/pla12x8cm (lot#srg1299x). 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. The product was used for therapeutic treatment of a left inguinal hernia. It was reported that after implant, the patient experienced chronic pain, recurring seroma and infection. Post-operative patient treatment included neurectomy.
 
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Brand NamePERMACOL
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
tracy landers
5920 longbow drive
boulder,co, CT 80301
3035816943
MDR Report Key9260861
MDR Text Key164888642
Report Number9617613-2019-00180
Device Sequence Number1
Product Code FTM
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
Type of Report Initial,Followup,Followup,Followup
Report Date 02/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Model NumberP101015
Device Catalogue NumberP101015
Device Lot NumberAQG0299
Was Device Available for Evaluation? No
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/12/2016
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: 10/31/2019 Patient Sequence Number: 1
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