MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE BASIC CATARACT PACK OPO70 (CPCAM)393; GENERAL SURGERY TRAY (KIT)

Model Number	SEY54CPCAN
Health Effect - Clinical Code	Rash (2033)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer stated that one of their patients developed a rash to the eyes and surrounding area following an ophthalmic surgery.The component source was unknown but the customer felt it could possibly be from the transparent dressing td-24cns2 from the basic cataract pack/ sey54cpcan.The patient was treated with prednisolone acetate 1% 1gtt both eyes, topical bacitracin/polysporin and topical hydrocortisone 1% on surrounding area and oral cephalexin.The rash resolved.A sample was not received from the customer for evaluation and a review of the device history record could not be reviewed since the lot number was not provided.The component td24cns2 is a non-sterile product.The transparent dressing is intended to use on wound care application, securing objects to skin and as a secondary dressing.Six bio compatibility tests in year 2015 were conducted.There was no abnormality found on the test result.Based on the limited information available, the root cause could not be determined and no further action will be taken at this time.The complaint information was informed to the relevant sectors for their awareness and we will continue to monitor the trend of this type of incident.
Event or Problem Description
The customer stated that one of their patients developed a rash to the eyes and surrounding area following an ophthalmic surgery.The component source was unknown but the customer felt it could possibly be from the transparent dressing td-24cns2 from the basic cataract pack/ sey54cpcan.The patient was treated with prednisolone acetate 1% 1gtt both eyes, topical bacitracin/polysporin and topical hydrocortisone 1% on surrounding area and oral cephalexin.The rash resolved.

• Brand Name: BASIC CATARACT PACK OPO70 (CPCAM)393
• Common Device Name: 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: 7554853
• Report Number: 1423537-2018-00207
• Device Sequence Number: 2412769
• Product Code: LRO
• UDI-Device Identifier: 10887488555294
• UDI-Public: 10887488555294
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: SEY54CPCAN
• Device Catalogue Number: SEY54CPCAN
• Device Lot Number: NONE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other