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

Device Problem Insufficient Information (3190)

Patient Problem Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.

Event Description

It was reported in a journal article entitled: outcome of angle surgery in children with aphakic glaucoma author(s): erick d.Bothun, md, yan guo, md, phd, stephen p.Christiansen, md, c.Gail summers, md, jill s.Anderson, md, martha m.Wright, md, natalia y.Kramarevsky, md, and mary g.Lawrence, md, mph citation: j aapos 2010;14:235-239; doi: 10.1016/j.Jaapos.2010.01.005.This retrospective study aimed to investigate the outcome of trabeculotomy and/or goniotomy for pediatric aphakic glaucoma.Between 1990 and 2006, 14 eyes from 11 patients (n=6 unilateral and n=5 bilateral; age ranged from 1 day to 10 months) with aphakic glaucoma underwent trabeculotomy and/or goniotomy.One patient who underwent trabeculotomy had subretinal passage of 6.0 prolene suture which was removed uneventfully.This patient later developed a linear, retinal pigment epithelial irregularity, but no further complication noted.The authors conclude that trabeculotomy and goniotomy can be successful in obtaining glaucoma control when surgical intervention is indicated for pediatric aphakic glaucoma, and that angle procedures may obviate or reduce the need for filtering, shunting, or cyclodestructive procedures.No further information is available.

• Brand Name: PROLENE POLYPROPYLENE SUTURE
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7578841
• MDR Text Key: 110392140
• Report Number: 2210968-2018-73354
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133356
• 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: 05/25/2018

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/07/2018
• 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
• Patient Age: 10 MO