MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; PATEWOOD MINOR PROCEDURE

Model Number DYNJ51729B

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/19/2023

Event Type  Injury  

Event Description

According to the facility on (b)(6) 2023 during a procedure "raytec frayed and md had to pick a piece out of the patient's incision".

Manufacturer Narrative

According to the facility on (b)(6) 2023 during a procedure "raytec frayed and md had to pick a piece out of the patient's incision".Per the facility the surgeon was using "adson forceps to place the raytec in the desired location".Per the facility the surgeon was able to remove the pieces from the patient.Per the facility there was no injury to the patient and no follow up care required.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 requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline Industries, Inc.
• Type of Device: PATEWOOD MINOR PROCEDURE
• 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: 17075403
• MDR Text Key: 316666456
• Report Number: 1423395-2023-00027
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10193489285161
• UDI-Public: 10193489285161
• 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: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DYNJ51729B
• Device Catalogue Number: DYNJ51729B
• Device Lot Number: 23CBD530
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2023
• 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