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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); Unspecified Infection (1930); Seroma (2069)
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. Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? if yes, provide details of event and specific product code. Can specific patient demographics be provided for each of the subjects of this article? if yes, please include: date and type of procedure, where procedure was performed, specific medical/surgical intervention per patient, product involved, pre-existing conditions. Are the product code and lot numbers available for ethicon devices used? citation: hernia 2000;4:202-205. (b)(4).
 
Event Description
It was reported in journal article "surgical treatment of incisional hernias with marked loss of substance¿ that the authors report their experience with a surgical technique in which the peritoneum is integrated with an absorbable prosthesis and the nonabsorbable prosthesis is positioned in the neo-pre-peritoneal plane. From january 1992 to january 2000, patient underwent surgery for large incisional hernias (lih) that presented an effective loss of substance of the abdominal wall. The patient may have experienced early complication of seroma which was aspirated, infection of abdominal wall treated with antibiotic therapy and hematoma which was aspirated. The patient may have experienced late complication of intestinal sub-occlusion treated successfully with medical therapy, cutaneous-prosthetic fistula and subacute infection of the abdominal wall. 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 Key7152113
MDR Text Key95963318
Report Number2210968-2017-72029
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K810428
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 12/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2017
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: 12/28/2017 Patient Sequence Number: 1
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