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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 P152030
Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Corneal Pannus (1447); Adhesion(s) (1695); Failure of Implant (1924); Unspecified Infection (1930); Ischemia (1942); Necrosis (1971); Hernia (2240); Injury (2348); Impaired Healing (2378); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
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 hernia. It was reported that after implant, the patient experienced recurrent hernia due to failure of the mesh, adhesions and degradation of the mesh. Treatment provided for these conditions include removal surgery.
 
Manufacturer Narrative
Additional info: this information was received as a part of an extensive mesh litigation submission to medtronic.  the fda was notified of this large complaint receipt.   due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. 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. It was reported that after implant, the patient experienced recurrent hernia due to failure of the mesh, adhesions, pannus formation, necrosis and infection of abdominal wall, degradation of the mesh, cholecystitis. Treatment provided for these conditions include removal surgery, excisional debridement of the abdominal wall with placement of a wound vac, dehiscence of abdominal, ischemia of the abdominal wall flap, removal of large area of necrotic skin, panniculectomy and open cholecystectomy.
 
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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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key7970012
MDR Text Key123867785
Report Number9617613-2018-00106
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 10/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP152030
Device Catalogue NumberP152030
Device Lot Number09B1308
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
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: 10/16/2018 Patient Sequence Number: 1
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