MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE

Device Problem Insufficient Information (3190)

Patient Problems Post Operative Wound Infection (2446); Ptosis (2620); Not Applicable (3189)

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.Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? citation: biomed research international volume 2015, article id 759793, 7 pages; http://dx.Doi.Org/10.1155/2015/759793.(b)(4).

Event Description

It was reported via journal article: "title : effectiveness of the lower eyelid suspension using fascia lata graft for the treatment of lagophthalmos" due to facial paralysis.Author : selam yekta sendul, halil huseyin cagatay, burcu dirim, mehmet demir, zeynep acar, ali olgun, efe can, and dilek guven.Citation: biomed research international volume 2015, article id 759793, 7 pages; http://dx.Doi.Org/10.1155/2015/759793.The purpose of this clinical study was to evaluate of functional and cosmetic effectiveness of lower eyelid sling technique with fascia lata graft in patients with lagophthalmos due to facial paralysis.Between september 2011 and january 2014, 10 patients (4 males, 6 females) with age ranging from 19 to 75 years who underwent lower eyelid sling surgery with a fascia lata graft were included in this study.During the procedure, the fascia lata graft was passed under the anterior leg of the inner canthal tendon upwards through the previously formed graft bed and was fixed by suturing with a 6/0 prolene suture both the graft itself and the anterior leg of the tendon.Four patients who developed eyebrow ptosis due to facial paralysis underwent direct browpexy as secondary surgery whereas one patient with ongoing postoperative punctum eversion and eyelid ectropion underwent punctum eversion correction surgery as secondary surgical intervention.The lateral end of the fascia lata was taken out fromthe opened bone inside out and it was fixed in an overlapping fashion by suturing with a 6/0 prolene suture.The periost tissue was closed with a 6/0 vicryl suture.Then, the inner and outer cantus areas were closed firstly in the subcutaneous area with a 6/0 vicryl suture and secondly on the skin with a 6/0 prolene suture.In one patient, wound infection developed in the leg (fascia lata harvested area) whereas one patient developed suture reaction in the medial canthal area.These infections were treated with systemic antibiotherapy.Other than that, no complications were observed.In conclusion, the lower eyelid sling technique with fascia lata, despite its long surgical time, is an effective and alternative method of treatment for both ocular surface protection and cosmetic appearance.

• Brand Name: PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7627311
• MDR Text Key: 111984966
• Report Number: 2210968-2018-73648
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/21/2018
• 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