MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MESH TSL - PERMACOL¿; MESH, SURGICAL, POLYMERIC

Model Number 5110-100

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Hernia (2240); Radiation Exposure, Unintended (3164)

Event Date 07/01/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient unknowingly received a mesh implant to repair an incisional hernia.The hernia appeared after surgery to remove bowel cancer and the patient noticed that the hernia seemed to return and is much bigger than before and have been experiencing extreme discomfort in the hernia repair site.They said they can feel the mesh moving and they are concerned that something might burst.This caused extreme discomfort, stress, anxiety and pain.Subsequent visits to the surgeon and ct scans showed that the mesh has moved and that her small intestine has a new hernia that had appeared outside of the mesh.The surgeon first advised the patient to do not touch it.The doctor advised that the mesh used was not one that was problematical and that there was no alternative.The hernia and discomfort had increased over time and after their most recent scans and visits to the surgeon, they advised the patient against any further action as they said it would be too dangerous to remove and that the patient could die as a result of any further operations.They said that nothing was going to burst and that the pain and discomfort could be relieved if the patient lost some weight.They advised the patient to just manage the pain and live with it.They would strongly advise against any further surgery to remove the mesh or repair the hernia and offered to recommend they patient for a second opinion from a colleague if they wanted that option.

• Brand Name: MESH TSL - PERMACOL¿
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8203946
• MDR Text Key: 131644548
• Report Number: 9612501-2018-02311
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2018
• Device Model Number: 5110-100
• Device Catalogue Number: 5110-100
• Device Lot Number: 13B12-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/28/2018
• 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): Required Intervention