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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

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ETHICON INC. VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Does the surgeon believe there was any deficiency with the ethicon products used in this procedure? citation: cardiovasc intervent radiol (2015) 38:1640¿1644. Doi 10. 1007/s00270-015-1136-x.

 
Event Description

It was reported in journal article ¿endovascular repair of renal artery anastomotic pseudoaneurysm following living donor kidney transplant¿ that the authors present the case of a pseudoaneurysm at the anastomosis of two donor renal arteries that were joined to each other to form a single renal artery, which in turn was joined to the recipient¿s aorta. The patient with end-stage renal disease secondary to obstructive uropathy received a renal transplant from a living unrelated donor. During closure of lateral abdominal musculature and fascia, tissue became shredded by suture placement and the resulting 3. 5 cm was closed with a piece of mesh. The patient¿s postoperative course was remarkable for low urine output and an escherichia coli positive wound culture on post-operative day 1, treated with cefepime. Additional information has been requested.

 
Manufacturer Narrative

Product complaint # ==> pc-000082491 corrected information: ¿ it was reported that this device is not malfunction reportable; there is no reported product deficiency and no early or late postoperative complications from the use of the device. Therefore, this medwatch report is not reportable.

 
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Brand NameVICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer (Section G)
ETHICON INC.
3348 pulliam st
san angelo TX 76905 4403
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key7148651
MDR Text Key95847993
Report Number2210968-2017-71981
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK810428
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type LITERATURE
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/11/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/27/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2018
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: 12/27/2017 Patient Sequence Number: 1
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