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

Model Number DYNJ51730B

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/04/2023

Event Type  Injury  

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 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.
• Type of Device: 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
• MDR Text Key: 314288422
• Report Number: 1423395-2023-00019
• Device Sequence Number: 1
• Product Code: FTN
• UDI-Device Identifier: 10889942975662
• UDI-Public: 10889942975662
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: DYNJ51730B
• Device Catalogue Number: DYNJ51730B
• Device Lot Number: 23ABO917
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other