MAUDE Adverse Event Report: ETHICON INC. VICRYL POLYGLACTIN 910 SUTURE; SUTURE, ABSORBABLE, SYNTHETIC

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Pain (1994); No Code Available (3191)

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.Can you provide the operative report for your procedures? what date did you present with symptoms after the 2006 procedure? what date did the issue begin after the 2007 procedure? what was your surgeon opinion regarding the symptoms? did you receive any medical treatment for your symptoms? what was the surgeon opinion of the causative factors for your infection post op? were any cultures taken of the sores? what were the results of the cultures? what is your surgeon¿s name and contact information? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation?.

Event Description

It was reported that the patient underwent an oophorectomy procedure on (b)(6) 2007 and the suture was used.Following the procedure, the patient continued to experience pain.Two weeks ago the patient developed some sores where the right abdominal incision had been for her oophorectomy and noticed the suture started to come out of the patient were described as cream-colored and softer.As the patient stated, she currently has a full body staph infection that is currently being cultured and analyzed.Additional information has been requested.

• Brand Name: VICRYL POLYGLACTIN 910 SUTURE
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5930826
• MDR Text Key: 53999371
• Report Number: 2210968-2016-13324
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• 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?: No
• Date Manufacturer Received: 08/12/2016
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention