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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 P151520
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Purulent Discharge (1812); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Scar Tissue (2060); Seroma (2069); Hernia (2240); Impaired Healing (2378); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative
Concomitant device: mesh c-quir 10 x 14 (midline) (product id: 31540, lot number: 403699007). 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 an incisional hernia and a parastomal hernia. It was reported that after the underlay implant, the patient experienced mesh failure, seroma, infection, abscess, thickened/edematous fascia, free floating mesh, inflammation, necrotic tissue, non-healing wound, purulent material, keloid scar, and recurrence. Post-operative patient treatment included revision surgery, drainage of abscess, wound irrigated, wound packed, debridement of abdominal wall infected mesh, keloid scar excised, and removal of mesh.
 
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Brand NamePERMACOL
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
UK GU11 1EJ
Manufacturer (Section G)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
UK GU11 1EJ
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key11536660
MDR Text Key241432604
Report Number9617613-2021-00011
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 Non-Healthcare Professional
Type of Report Initial
Report Date 03/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Model NumberP151520
Device Catalogue NumberP151520
Device Lot NumberAPK0031
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/09/2015
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: 03/20/2021 Patient Sequence Number: 1
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