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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. BOOT,SUTURE,STANDARD,YELLOW-IN-BLUE

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MEDLINE INDUSTRIES INC. BOOT,SUTURE,STANDARD,YELLOW-IN-BLUE Back to Search Results
Catalog Number DYNJSBY5
Device Problems Break (1069); Device Fell (4014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2021
Event Type  malfunction  
Manufacturer Narrative
It was reported, "product is falling apart while on the tips of instruments and falling into patients. " due diligence has been completed. No additional details are available related to the customer reported issue. Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer. Due to the reported nature of the incident and in an abundance of caution, this medwatch is being filed. No samples have been returned for evaluation. If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
 
Event Description
It was reported, "product is falling apart while on the tips of instruments and falling into patients. ".
 
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Type of DeviceBOOT,SUTURE,STANDARD,YELLOW-IN-BLUE
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093 2753
Manufacturer Contact
teresa maynard
three lakes drive
northfield, IL 60093-2753
2249311514
MDR Report Key12163532
MDR Text Key263414097
Report Number1417592-2021-00117
Device Sequence Number1
Product Code GAB
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
Report Date 07/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberDYNJSBY5
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 Received06/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/13/2021 Patient Sequence Number: 1
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