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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; DBD-SHOULDER ARTHROSCOPY PACK-LF
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MEDLINE INDUSTRIES INC.; DBD-SHOULDER ARTHROSCOPY PACK-LF Back to Search Results
Catalog Number DYNJ48490C
Device Problem Fluid/Blood Leak (1250)
Patient Problems Fall (1848); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/01/2021
Event Type  Injury  
Manufacturer Narrative
It was reported that a "massive amount of fluid" spilled off of the drape and onto the floor during use.Reportedly, a staff member slipped on the fluid, fell, and experienced "electrocution." despite multiple good faith attempts, the customer was unable or unwilling to provide any additional information related to the reported incident.It is unknown what procedure was being performed at the time of the incident, what electronic/electric device was in use during the procedure, what medical intervention or follow-up care was needed, and what the staff member's current status is.No patient impact was originally reported.The used procedure pack was originally reported as being discarded and the sample was not available to be returned for evaluation.Due to the reported incident, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
 
Event Description
It was reported that a "massive amount of fluid" spilled off of the drape and onto the floor during use.
 
Manufacturer Narrative
An unused drape sample was returned by the reporting facility for investigation.Sample investigation was completed on (b)(6) 2021.The returned sample was measured and found to meet product specifications.No issue was identified with the returned unused sample and the root cause was unable to be determined.If additional relevant information becomes available another supplemental medwatch will be filed.
 
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Type of Device
DBD-SHOULDER ARTHROSCOPY PACK-LF
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093 2753
MDR Report Key11684743
MDR Text Key246062372
Report Number1423395-2021-00019
Device Sequence Number1
Product Code OJH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 04/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberDYNJ48490C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2021
Date Manufacturer Received04/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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