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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 P101015
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Calcium Deposits/Calcification (1758); Diarrhea (1811); Vomiting (2144); Sleep Dysfunction (2517); No Code Available (3191); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative
Medtronic complaint report: pe:(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Per additional information received, preoperative diagnosis: type 3 paraesophageal hernia, gastroesophageal reflux disease. Postoperative diagnosis: type 3 paraesophageal hernia, gastroesophageal reflux disease. Operation: diagnostic laparoscopy, laparoscopic repair of type 3 paraesophageal hernia, primary repair of esophageal hiatus with permacol overlay, partial gastrectomy, upper endoscopy. Post operative complaint: failed nissen fundoplication chest revealed significant pulmonary restriction.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter: mesh was placed inside the patient from a hernia operation. Since then, the patient has suffered from severe diarrhea, constipation and other stomach complications. The patient was told by a surgeon that the mesh left inside turned into calcium and now has stuck to the organs. Currently, the patient's stomach is in their chest, so the patient also suffers from insomnia because of the coughing and throwing up at night. The patient is unable to get the corrected surgery because of their health and complications from the 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
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key6981233
MDR Text Key106330237
Report Number9617613-2017-05127
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial,Followup,Followup
Report Date 11/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/26/2011
Device Model NumberP101015
Device Catalogue NumberP101015
Device Lot Number07B10-3
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2017
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: 10/26/2017 Patient Sequence Number: 1
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