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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

Product complaint #
=
> (b)(4), hernia occurred.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? source: colorectal disease.2015 sep; conference: 10th scientific and annual meeting of the european society of coloproctology dublin ireland.Conference start: 20150923 conference end: 20150925.Conference publication: (var.Pagings).17 :55.

Event Description

It was reported in journal article ¿long-term follow up of patients treated for enterocutaneous fistula¿ that the aim of this study was to objectify the incidence of incisional hernia and the effect on the quality of life in patients treated for enterocutaneous fistula.Patients treated for enterocutaneous fistula between 1990 and 2014 participated in this study, with a median follow-up of 6 years.A physical examination was performed to objectify an incisional hernia.The patient bridged with mesh may have experienced incisional hernia.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: 7151259
• MDR Text Key: 95936262
• Report Number: 2210968-2017-72013
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• 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: 12/01/2017

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: 12/01/2017
• 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