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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 Problems Fistula (1862); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Not Applicable (3189)
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.

 
Event Description

It was reported via journal article, ¿experience of posterior colporrhaphy in a tertiary referral centre ¿, that a study was conducted to assess outcome of patients who present to a colorectal pelvic floor clinic with a rectocele and undergo a posterior colporrhaphy. This was a retrospective review of patients undergoing a posterior colporrhaphy by the colorectal team, between 1987 and 2009, in a tertiary referral centre. There were 53 patients (median age 54 years [range 31-74]) included. The technique for posterior colporrhaphy was 40 (75%) suture, 7 (13%) with sphincter repair, 3 (6%) mesh and 3 (6%) repeat. Interventions for complications were: one (2%) control of primary haemorrhage, 1 (2%) drainage of infected wound haematoma, 1 (2%) removal of mesh due to vaginal pain and 1 (2%) repair of rectovaginal fistula. 39 (74%) patients had symptomatic improvement, 4 (8%) developed a recurrence and 10% (18%) did not improve.

 
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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.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key7149781
MDR Text Key95895090
Report Number2210968-2017-71994
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK810428
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 12/01/2017
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2017
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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