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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

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ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Seroma (2069); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.No specific patient information regarding events has been provided.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? citation: hernia.2015; 19: 267 271.Doi: 10.1007/s10029-014-1262-4.(b)(4).
 
Event Description
It was reported via journal article: "title: a comparative study of sutured versus bovine pericardium mesh abdominal closure after open abdominal aortic aneurysm repair" authors: c.Bali, j.Papakostas, g.Georgiou, g.Kouvelos, s.Avgos, e.Arnaoutoglou, g.Papadopoulos, m.Matsagkas citation: hernia.2015; 19: 267 271.Doi: 10.1007/s10029-014-1262-4 open abdominal aortic aneurysm (aaa) repair is followed by a high rate of incisional herniation.The purpose of this prospective randomized clinical study was to evaluate whether this post-operative complication could be avoided by a prophylactic implantation of a biological mesh.A total of 40 patients underwent open aaa and were included in the study.Of which, 20 patients were randomized under the suture fascia closure group (group a) and 20 patients were randomized under suture fascia closure reinforcement by an onlay mesh implantation.In the suture fascia closure group, after the aneurysm sac and posterior peritoneum was closed, a routine mass closure in a running 4:1 ratio pds 1-0 loop suture was made.Post-operative complication included seroma (n-1) which was treated with percutaneous drainage.It was concluded that the bovine pericardium mesh reinforcement of fascia closure in patients undergoing open aaa repair showed effectiveness and low complication rate in prophylaxis from incisional herniation.
 
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Brand Name
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
Type of Device
SUTURE, SURGICAL, ABSORBABLE
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7475274
MDR Text Key106973378
Report Number2210968-2018-72479
Device Sequence Number1
Product Code NEW
Combination Product (y/n)N
PMA/PMN Number
N18331
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other
Type of Report Initial
Report Date 03/23/2018
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? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/23/2018
Initial Date FDA Received05/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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