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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 Wound Dehiscence (1154); Conjunctivitis (1784); Inflammation (1932); 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. 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. What is the surgeon¿s opinion as the etiology of the reported issue? did any particular suture lead to the dehiscence and require intervention? was suture placed interrupted or continuous? was any suture breakages noticed for dehiscences? does the surgeon believe there was any deficiency with the mesh used in this procedure? citation: french journal of ophthalmology (2014) 37, 99-106. (b)(4).

 
Event Description

It was reported in journal article "results of natural hydroxyapatite implants covered with vicryl mesh in a series of 704 enucleations¿ that over a period of 12 years (november 1996 and december 2008) the authors evaluated the long-term tolerance of colonizable microporous natural hydroxyapatite implants enveloped in a mesh. Muscles were sutured in a position that is anatomical to the implant. Then the capsule was sutured by clearly separated stitches to avoid friction between the conjunctiva and the hydroxyapatite implant, which would induce a dehiscence and secretions. The conjunctiva was sutured. The patient may have developed conjunctival complication and eyelid was involved after insertion of the implant and may have experienced post-operative orbital cellulitis that required removal of the implant. The patient may have experienced conjunctival dehiscence with exposure of the implant and dehiscence was localized, with no repercussion on the conjunctiva. Small localized dehiscence may have been induced by the use of suturing muscles to the implant. Complications that include inflammation of the conjunctiva, minimal conjunctival dehiscence, conjunctivitis, and moderate ptosis were treated medically or were simply monitored. The patient may have undergone a second intervention of a simple surgical procedure. The patient may have experienced more serious dehiscence with abundant secretion requiring another intervention of oral mucosal graft or removal of the implant combined with a dermo-fatty graft or fascia lata graft, which resulted in a relief of symptoms. In a univariate analysis, the major risk factors for the development of complications were age, the disease treated, and the diameter of the implant, with the diameter of the implant being the only risk factor for complications in the multivariate analysis. Additional information has been requested.

 
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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 Key7148938
MDR Text Key95857321
Report Number2210968-2017-71983
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeFR
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 12/11/2017
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
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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