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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SC003 SC-FORT MILL DSC CULLOM EYE PACK (CEDRE)133 EYE TRAY

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SC003 SC-FORT MILL DSC CULLOM EYE PACK (CEDRE)133 EYE TRAY Back to Search Results
Model Number SEYHDCEDRE
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Toxic Anterior Segment Syndrome (TASS) (4469)
Event Date 08/24/2020
Event Type  Injury  
Manufacturer Narrative

The investigation into the reported incident is ongoing while we continue to gather further details related to the event. A follow-up report will be filed once the results have been completed.

 
Event Description

Customer reported that during a cataract extraction with intraocular lens implant procedure, the mayo stand cover a8337cn from eye pack seyhdcedre was found to have a fuzzy layer after moving instruments around so a towel was placed over the mayo cover. There was no delay. The patient developed toxic anterior segment syndrome tass so customer is looking into all possible causes. Durozel eye drops were prescribed to treat the tass.

 
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Brand NameDSC CULLOM EYE PACK (CEDRE)133
Type of DeviceEYE TRAY
Manufacturer (Section D)
SC003 SC-FORT MILL
785 fort mill hwy.
fort mill SC 29707
Manufacturer (Section G)
SC003 SC-FORT MILL
785 fort mill hwy.
fort mill SC 29707
Manufacturer Contact
patricia tucker
3651 birchwood drive
waukegan, IL 60085
8478874151
MDR Report Key10577570
MDR Text Key208293459
Report Number1423537-2020-00528
Device Sequence Number1
Product Code OJK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSEYHDCEDRE
Device Catalogue NumberSEYHDCEDRE
Device LOT Number449922
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/23/2020 Patient Sequence Number: 1
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