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U.S. Department of Health and Human Services

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

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DAVIS & GECK CARIBE LTD MESH TSL - PERMACOL¿ MESH, SURGICAL, POLYMERIC Back to Search Results
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.
 
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Brand NameMESH TSL - PERMACOL¿
Type of DeviceMESH, 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 Key8203946
MDR Text Key131644548
Report Number9612501-2018-02311
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 12/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/26/2018
Device Model Number5110-100
Device Catalogue Number5110-100
Device Lot Number13B12-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2018
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: 12/28/2018 Patient Sequence Number: 1
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