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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 P100510
Device Problems Migration or Expulsion of Device (1395); Product Quality Problem (1506); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Edema (1820); Fistula (1862); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Scar Tissue (2060); Discharge (2225); Hernia (2240); Peritonitis (2252); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Fibrosis (3167); 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. The product was used for therapeutic treatment of a recurrent umbilical hernia. It was reported that after implant, the patient experienced strangulated incisional hernia, drainage of chronic sinus tract, adhesions, incarcerated and strangulated small bowel, necrotic abdominal wound status post closed loop obstruction, bowel had a dusky appearance, scar tissue, ascites, abdominal wall abscess, chronic wound with exposed bowel, omentum densely adherent to anterior abdominal wall, transverse colon was densely adherent, small bowel obstruction, loops of small bowel densely adherent, twisting and torsion of bowel, thickened area of mesentery and small bowel in jejunum, mesh on the right side was shrunken and wrinkled, non-healing surgical wound sequela, purulent material in sinus tract, and infected mesh. Post-operative patient treatment included umbilical hernia repair, removal of umbilicus, wound closure, incisional hernias repaired with sutures, lysis of adhesions, resection of necrotic small bowel, released of bowel from hernia sac, debridement of exudate in superior portion of wound, debridement of skin necrosis, subcutaneous tissue, fat, necrotic muscle and fascia as well as recurrent ventral hernia repair with small bowel obstruction (partial) repair with mesh, abdominal wall reconstruction, placement of drains, excision of skin and subcutaneous tissue, repair of abdominal hernia, old scar tissue was removed, interloop adhesions were lysed, portions of a previous mesh were also removed, incision and drainage of large fluid collection, subcutaneous tissue, and abdominal wall abscess, excisional debridement of abdominal wall, recurrent incisional hernia repair with mesh, adhesions of entire anterior abdominal wall were taken down, recurrent defect repaired with sutures, small bowel resection was performed, mesentery defect was closed with sutures, removal of intra-peritoneal mesh, sinus tract was excised in its entirety, and removal of infected intra-abdominal mesh.
 
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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 Key8764210
MDR Text Key150134680
Report Number9617613-2019-00113
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
Report Date 02/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/22/2007
Device Model NumberP100510
Device Catalogue NumberP100510
Device Lot Number05B27-9
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2019
Was Device Evaluated by Manufacturer? No Answer Provided
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: 07/05/2019 Patient Sequence Number: 1
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