MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE EYE PACK 1030 (EYPEC)589; GENERAL SURGERY TRAY (KIT)

Model Number SEY6VEYPED

Device Problem Material Frayed (1262)

Patient Problems Abrasion (1689); Corneal Abrasion (1789)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.

Event Description

Fraying of the drape caused corneal abrasions and sticky adhesive caused skin abrasions.

Manufacturer Narrative

Based on our investigation and review of the device history record, aperture drape d1030nsa, lot# 1938cc1 was manufactured on july 13th, 2018.The device history record review did not indicate any exception that could lead to the reported incident.A review of the batch history record did not indicate any quality issues.All operators are certified in their respective operations and the operators or the quality inspector did not identify this condition during their process and continuous inspection.The drape is made with qualified, tested, and approved materials.A review of complaints over the last 12 months indicated that this is an isolated incident reported for this particular catalog number.Based on the limited information available at this time and no product sample provided, the root cause could not be determined.If a sample is provided at a later date, the investigation will be re-opened and an addendum report will be provided.We will continue monitoring our customer complaints data base for this and any other issues reported of the same nature in this catalog.

• Brand Name: EYE PACK 1030 (EYPEC)589
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• MDR Report Key: 8191350
• MDR Text Key: 131221034
• Report Number: 1423537-2018-00248
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10888439016475
• UDI-Public: 10888439016475
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SEY6VEYPED
• Device Catalogue Number: SEY6VEYPED
• Device Lot Number: 988778
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other