MAUDE Adverse Event Report: ETHICON INC. VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

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.

• Brand Name: VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT
• Type of Device: MESH, 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 Key: 7152113
• MDR Text Key: 95963318
• Report Number: 2210968-2017-72029
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K810428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• 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 Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention