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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 Abscess (1690); Fistula (1862); Unspecified Infection (1930); Obstruction/Occlusion (2422); 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. (b)(4).

 
Event Description

It was reported via journal article, ¿use of negative pressure wound therapy in the management of infected abdominal wounds containing mesh: an analysis of outcomes¿ that a study was conducted to document the outcomes of using negative pressure wound therapy (npwt) as an adjunctive treatment for abdominal wound infections with exposed mesh. For each patient, total hospital length of stay (los), complications and procedures performed were documented prior to and post-npwt initiation to determine efficacy of npwt in the treatment of this type of wound. A non-randomized, retrospective review of medical records for 21 consecutive patients with infected abdominal wounds treated with npwt was conducted. Inclusion criteria into the study were patients with a primary diagnosis of infected abdominal wound with exposed mesh following a failed acute abdominal wall closure or ventral hernia repair from 1999 to 2004. Wounds were classified into 3 different groups according to type of mesh used: pp mesh (marlex, bard vascular; n=8), knitted pg mesh, and a pp/expanded polytetrafluoroethylene composite mesh (bard composix; n=8). Twenty-one patients (6 men, 15 women; mean age 71 years [range 36-87]) with abdominal wounds with exposed, infected mesh were treated with npwt. Among patients with pg mesh, all were hypoalbuminemic with wounds secondary to acute abdominal closure and intra-operative polymicrobial cultures (mrsa and p. Aeruginosa). All pg meshes were left in situ and all subsequently healed. Complications pre-npwt and post-npwt include: fistula (pre: n=5; post: n=1 [pp mesh]), small bowel obstruction (pre: n=3; post: n=0), abscess (pre: n=12; post: n=1), sinus tracts (pre: n=4; post: n=3 [composite mesh]). Prior to initiation of npwt and associated mesh extraction and debridements, 5 patients were treated for fistula, 14 were admitted for drainage of abscesses for a total of 20 such admissions, 4 for sinus tracts and 3 for small bowel obstruction. Following initiation of npwt, three, 3 patients with retained composite mesh were treated for sinus tracts, 2 abscesses developed requiring incision and drainage, and 1 patient with retained pp mesh was treated for an enterocutaneous fistula. The results suggest a reduction in the number of complications with the use of npwt versus standard care.

 
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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 Key7149286
MDR Text Key95867138
Report Number2210968-2017-71989
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 LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 12/01/2017
1 Device Was Involved in the Event
0 PatientS WERE 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? Yes
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

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