MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; GAUZE,SPONGE,4"X4",8PLY,NS,LF,4000/CS

Catalog Number	PRM21408C
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported fragments of nonsterile 100% cotton woven gauze sponge had come off on to a patient's surgical site during a mohs procedure.Email received by facility representative, with additional information related to this incident.The reporter states on (b)(6) 2020 fragments of nonsterile 100% cotton woven gauze sponge had come off on to a patient's surgical site at the end of a mohs procedure.Reporter states, the fragments were removed with instruments and irrigation.No serious injury was reported.Reporter states no samples are available for return and evaluation.Due to the reported incident, medical intervention 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 or Problem Description
It was reported fragments of nonsterile 100% cotton woven gauze sponge had come off on to a patient's surgical site during a mohs procedure.

• Common Device Name: GAUZE,SPONGE,4"X4",8PLY,NS,LF,4000/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10901279
• Report Number: 1417592-2020-00141
• Device Sequence Number: 11452663
• Product Code: NAB
• UDI-Device Identifier: 10080196694013
• UDI-Public: 10080196694013
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

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: PRM21408C
• Device Lot Number: 6052006036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/25/2020
• 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: 68 YR