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U.S. Department of Health and Human Services

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

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MEX03 MEXICO-JUAREZ PRESOURCE EYE PACK 1030 (EYPEC)589 GENERAL SURGERY TRAY (KIT) Back to Search Results
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.

 
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Brand NameEYE PACK 1030 (EYPEC)589
Type of DeviceGENERAL SURGERY TRAY (KIT)
Manufacturer (Section D)
MEX03 MEXICO-JUAREZ PRESOURCE
c. arcadia 1580 , col. terraza
cd.juarez , chihuahua CP 32 599
MX CP 32599
Manufacturer (Section G)
MEX03 MEXICO-JUAREZ PRESOURCE
c. arcadia 1580 , col. terraza
cd.juarez , chihuahua CP 32 599
MX CP 32599
Manufacturer Contact
patricia tucker
3651 birchwood drive
waukegan, IL 60085
8478874151
MDR Report Key8191350
MDR Text Key131221034
Report Number1423537-2018-00248
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE 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 Received12/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSEY6VEYPED
Device Catalogue NumberSEY6VEYPED
Device LOT Number988778
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/05/2018
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/21/2018 Patient Sequence Number: 1
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