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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
Catalog Number VICRYLMSHUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Unspecified Infection (1930); Seroma (2069); Post Operative Wound Infection (2446)
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. The single complaint was reported with multiple events. There are no additional details regarding the additional events. Citation: hernia. 2018 mar; conference: 2018 international hernia congress. United states. 22 (1 supplement 1) :s69. Please see referenced article attached. (b)(4).

 
Event Description

It was reported in a journal article with title: intraperitoneal polypropylene mesh: another perspective. This retrospective descriptive study of a prospective cohort aimed to determine the incidence of enterocutaneous fistulas (ecfs) developed after elective incisional hernia (ih) repair using intraperitoneal uncoated polypropylene (ppe) mesh. Between jan1992 and dec2013, 695 ih repairs were performed using intraperitoneal uncoated ppe mesh. In 188 patients (27%) it was not possible to place the omentum between the mesh and bowel; therefore, in 69 patients (9. 92%) the ppe mesh was placed over the bowel, whereas in 119 patients (17. 12%) a vicryl mesh was placed between the bowel and ppe mesh. Postoperative complications included seroma (n=5. 9%), hematoma (n=4. 3%), wound infection (n=4. 8%) and mesh infection (n=4. 0%). Based on these results, the placement of intraperitoneal uncoated ppe mesh for elective ih repair might be a safe procedure that is not associated with ecf formation.

 
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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 NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-SAN ANGELO
3348 pulliam st
san angelo TX 76905
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8264500
MDR Text Key133736760
Report Number2210968-2019-78505
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeAR
PMA/PMN NumberK810428
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial
Report Date 01/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/21/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberVICRYLMSHUNK
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/21/2019 Patient Sequence Number: 1
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