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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 P101828
Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Calcium Deposits/Calcification (1758); Failure of Implant (1924); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Abdominal Distention (2601); Fibrosis (3167)
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 mesh failure, adhesions, and bowel obstruction. Post-implant treatment included revision/removal surgery and adhesion removal.
 
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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 Key9610286
MDR Text Key176231085
Report Number9617613-2020-00008
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,Followup
Report Date 06/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/29/2010
Device Model NumberP101828
Device Catalogue NumberP101828
Device Lot Number07B07-3
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2020
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: 01/21/2020 Patient Sequence Number: 1
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