MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; NEURO BACK PACK-LF

Catalog Number	DYNJ66797
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Email received by senior inventory clerk for surgical services, queen of the valley medical center, with additional information in regards to this complaint.Reporter confirms this incident occurred (b)(6) 2021 in the middle of a laminectomy procedure.Reporter further confirms, "large strands were coming loose from the gauze and needed to be removed that were on the incision." reporter state's, the frayed material was removed by hand by both the surgeon and technician.No serious injury or impact on the procedure had incurred.Reporter did not give an update as to how the patient is doing at this time.Samples are available for return and evaluation.Due to the reported incident, medical intervention and in an abundance of caution, a medwatch will be filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported large strands were coming loose from the gauze and needed to be removed from the incision.

• Common Device Name: NEURO BACK PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11210374
• Report Number: 1423395-2021-00007
• Device Sequence Number: 14468569
• Product Code: OJG
• UDI-Device Identifier: 10193489383027
• UDI-Public: 10193489383027
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ66797
• Device Lot Number: 20JKB868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR