MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline Industries, Inc.; DBD-PATEWOOD MAJOR BREAST

Model Number	DYNJ51730B
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2023 the patient was undergoing a procedure when a "fluffy blob of blue fuzz almost 1 cm long was found in the incision".Per the facility they were able to retrieve the towel specimen from the surgical field without injury to the patient.Per the facility there was no impact to the patient or procedure and the item was removed from the surgical field and placed in a specimen container.No additional information is available at this time.The sample is not available for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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
According to the facility on 04/04/23 the patient was undergoing a procedure when a "fluffy blob of blue fuzz almost 1 cm long was found in the incision".

• Brand Name: Medline Industries, Inc.
• Common Device Name: DBD-PATEWOOD MAJOR BREAST
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16844082
• Report Number: 1423395-2023-00019
• Device Sequence Number: 6823622
• Product Code: FTN
• UDI-Device Identifier: 10889942975662
• UDI-Public: 10889942975662
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: DYNJ51730B
• Device Catalogue Number: DYNJ51730B
• Device Lot Number: 23ABO917
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown