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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC. DBD-CATARACT PACK

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MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC. DBD-CATARACT PACK Back to Search Results
Model Number DYNJ44929C
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/04/2020
Event Type  Malfunction  
Manufacturer Narrative

It was reported that on (b)(6) 2020 during a cataract procedure, upon injection using a 3 ml syringe (a component of medline cataract pack (dynj44929c) flecks of debris, and sediment was injected into the patient's eye. The reporter states, "the debris was successfully irrigated out of the eye and per routine antibiotics were given. " the reporter states, "no injury was detected, no change in routine post-op care was indicated. The reporter states, "patient is doing beautifully. " sample has not been returned for evaluation. No further information is available at this time. Due to the nature of the reported incident and medical intervention provided this medwatch is being filed. If additional information becomes available, a supplemental medwatch will be filed.

 
Event Description

It was reported that during a cataract procedure, upon injection flecks of debris and sediment was injected into the patient's eye.

 
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Brand NameMEDLINE INDUSTRIES, INC.
Type of DeviceDBD-CATARACT PACK
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield, il
Manufacturer Contact
teresa maynard
three lakes drive
northfield, il 
9311514
MDR Report Key10454897
MDR Text Key209211375
Report Number1423395-2020-00021
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 COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDYNJ44929C
Device Catalogue NumberDYNJ44929C
Device LOT Number20BDB783
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/11/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 08/26/2020 Patient Sequence Number: 1
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