MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES MESH TSL - PERMACOL¿; MESH, SURGICAL

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

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.

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.

• Brand Name: MESH TSL - PERMACOL¿
• Type of Device: MESH, 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 Key: 6981233
• MDR Text Key: 90395080
• Report Number: 9617613-2017-05127
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2011
• Device Model Number: P101015
• Device Catalogue Number: P101015
• Device Lot Number: 07B10-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 87