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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE DUALMESH BIOMATERIAL MESH, SURGICAL, POLYMERIC

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W.L. GORE & ASSOCIATES GORE DUALMESH BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1DLMC05
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems Abscess (1690); Pain (1994); Not Applicable (3189); No Code Available (3191)
Event Date 11/02/2009
Event Type  Injury  
Manufacturer Narrative

(b)(4). (b)(6). It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence¿.

 
Event Description

It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2009 whereby a gore dualmesh® biomaterial device was implanted. The complaint alleges that on (b)(6) 2009, the gore device was explanted. It was reported the patient alleges the following injuries: pain and discomfort, change in bowel habits, severe adhesions, mesh removal, and additional surgeries to repair hernia. Additional event specific information and medical records were not provided but have been requested.

 
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Brand NameGORE DUALMESH BIOMATERIAL
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
kathy titus
9285263030
MDR Report Key7639222
MDR Text Key112379989
Report Number3003910212-2018-00036
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK992189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation OTHER CAREGIVERS
Type of Report Initial,Followup,Followup,Followup
Report Date 10/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/22/2013
Device MODEL Number1DLMC05
Device Catalogue Number1DLMC05
Device LOT Number06295534
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/23/2008
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: 06/26/2018 Patient Sequence Number: 1
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