MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; LAMINECTOMY PACK

Catalog Number	DYNJ17333G
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that during a laminectomy procedure the surgeon noticed the operating room (or) towel shedding lint into the surgical site which required irrigation to remove.There was no serious injury or follow-up care reported related to this event.There was no reported impact to the patient or to the laminectomy procedure.The patient was under general anesthesia during the event but it did not delay the laminectomy procedure.A sample was returned to the manufacturer for evaluation.The reported linting of the operating room (or) towel was confirmed.Due to the need for medical intervention this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a laminectomy procedure the surgeon noticed the operating room (or) towel shedding lint into the surgical site which required irrigation to remove.

• Common Device Name: LAMINECTOMY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7286483
• Report Number: 1423395-2018-00005
• Device Sequence Number: 1109992
• Product Code: OJH
• UDI-Device Identifier: 10889942286430
• UDI-Public: 10889942286430
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2018

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
• Operator of Device: Physician
• Device Catalogue Number: DYNJ17333G
• Device Lot Number: 17CD0319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 02/21/2018
• 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