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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline Industries, Inc.; MP NEURO PACK

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MEDLINE INDUSTRIES LP Medline Industries, Inc.; MP NEURO PACK Back to Search Results
Model Number DYNJ49951J
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/28/2022
Event Type  Injury  
Manufacturer Narrative
According to the facility the 'raytec gauze were coming apart and leaving fragments in the patient which had to be manually retrieved'.Per the facility the fragments were noticed in the beginning and the middle of the procedure.The fragments were manually retrieved and removed from the patient and the product was removed from the field and replaced with another.According to the facility the procedure was completed after extended surgical time, and there was no reports of serious injury to the patient.The sample was requested to be returned for evaluation but was not available.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.
 
Event Description
According to the facility the 'raytec gauze were coming apart and leaving fragments in the patient which had to be manually retrieved'.
 
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Brand Name
Medline Industries, Inc.
Type of Device
MP NEURO 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 Key14187143
MDR Text Key289951473
Report Number1423395-2022-00014
Device Sequence Number1
Product Code OJG
UDI-Device Identifier10193489857627
UDI-Public10193489857627
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 04/22/2022
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 Model NumberDYNJ49951J
Device Catalogue NumberDYNJ49951J
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/28/2022
Initial Date FDA Received04/22/2022
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;
Patient Age71 YR
Patient SexMale
Patient Weight85 KG
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