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 Erosion (1750); Granuloma (1876); Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to the fda: 07/21/2017.(b)(4).If the device or further details are received at the later date a supplemental medwatch will be sent.No specific patient information regarding additional events has been provided.Attempts are being made to obtain the following information.If further details are received at the 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 / vicryl suture, caused or contributed to: recurrence, suture granuloma, combo: antibiotic, steroid ointment, suture exposure, infection, iodine sterilization of the skin of the upper eyelid, reoperation ? if yes, provide details of event and specific suture product type.Can specific patient demographics be provided for each of the subjects of this article? if yes, please include: date 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 devices used vicryl suture?.

Event Description

It was reported in a journal article that the patient underwent a frontalis suspension with the open technique fox procedure between (b)(6) 2010 and (b)(6) 2013 and the suture was used for brow and the eyelid incision closures.Following the procedure, the patient possibly experienced partial or complete recurrence, suture granuloma at the middle suprabrow incision, which responded well to a combination of antibiotic and steroid ointment with no need for surgical removal, suture exposure at the middle suprabrow incision and/or at the skin crease incision within an average time of two months postoperatively.It was possible that the patient underwent a reoperation carried out under a complete umbrella of broad-spectrum antibiotics with closure of the wound at two different layers.It was also reported that the patient possibly experienced infection which was treated with iodine sterilization of the skin of the upper eyelid, topical antibiotic ointment, and systemic antibiotic and underwent a reoperation after skin infection was controlled.It was possible that the patient had overcorrection where the upper eyelid returned to normal position without massage or surgical intervention eight weeks after the procedure.During this period, only lubricants were used.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: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6733928
• MDR Text Key: 80753785
• Report Number: 2210968-2017-33073
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• PMA/PMN Number: K022269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: No
• 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