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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; MINOR PACK
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MEDLINE INDUSTRIES LP; MINOR PACK Back to Search Results
Catalog Number 200490598
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/31/2022
Event Type  Injury  
Event Description
According to the facility during a procedure the 'insulated bovie tip came out of the bovie pencil and had to be fished out of the wound'.
 
Manufacturer Narrative
According to the facility during a procedure the 'insulated bovie tip came out of the bovie pencil and had to be fished out of the wound'.The sample is not available to be returned for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
 
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Type of Device
MINOR PACK
Manufacturer (Section D)
MEDLINE INDUSTRIES LP
three lakes drive
northfield IL 60093
Manufacturer Contact
justin herrmann
three lakes drive
northfield, IL 60093
MDR Report Key14196660
MDR Text Key290000232
Report Number1423395-2022-00015
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
Type of Report Initial
Report Date 04/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number200490598
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/31/2022
Initial Date FDA Received04/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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