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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL MESH, SURGICAL

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W.L. GORE & ASSOCIATES GORE SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL MESH, SURGICAL Back to Search Results
Catalog Number 1BSGC25
Device Problem Leak/Splash (1354)
Patient Problem Failure to Anastomose (1028)
Event Date 10/19/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4)- the review of the manufacturing paperwork verified that this lot met all pre-release specifications. The device remains implanted. Per the physician, he did not believe the device caused the leak.
 
Event Description
It was reported to gore that a patient underwent a colon resection on (b)(6) 2016 using gore® seamguard® bioabsorbable staple line reinforcement. The surgeon reported that on (b)(6) 2016 the patient developed an anastomotic leak and underwent surgery and was fitted with a colostomy bag.
 
Manufacturer Narrative
(b)(4).
 
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Brand NameGORE SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
Type of DeviceMESH, SURGICAL
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
cheryl hawke
301 airport rd.
elkton, MD 
9285263030
MDR Report Key6080279
MDR Text Key59222037
Report Number3003910212-2016-00064
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053200
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2018
Device Catalogue Number1BSGC25
Device Lot Number14916761
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/17/2016
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: 11/04/2016 Patient Sequence Number: 1
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