MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; XRAY DETECTABLE GAUZE FROM MINOR ACTION PACK

Catalog Number	DYNJ51754B
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the x-ray detectable gauze frayed in the wound during the excision of a lesion to the patient's back.Per report, fraying of the x-ray detectable gauze was noted in the middle of the procedure and a tissue forceps was used to successfully retrieve the frayed fibers of the x-ray detectable gauze from the patient.The patient was reportedly under local anesthesia at the time of the incident.No impact to the patient, the procedure, or the total length of the procedure was reported.The patient is reportedly doing well at this time with no report of any complications related to the reported event.There was no serious injury or follow-up care reported.Due to the reported incident, this medwatch is being filed.The sample was returned for evaluation and the complaint is confirmed.A root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that fraying of the x-ray detectable gauze was noted in the middle of the procedure and a tissue forceps was used to successfully retrieve the frayed fibers of the x-ray detectable gauze from the patient.

• Common Device Name: XRAY DETECTABLE GAUZE FROM MINOR ACTION PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8051260
• Report Number: 1423395-2018-00055
• Device Sequence Number: 1586421
• Product Code: FDE
• UDI-Device Identifier: 10889942668571
• UDI-Public: 10889942668571
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/08/2018

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: Health Professional
• Device Catalogue Number: DYNJ51754B
• Device Lot Number: 18FBB172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/08/2018
• 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
• Patient Age: 88 YR
• Patient Weight: 73