MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; GYN LAPAROSCOPY PACK-LF

Catalog Number DYNJ38401N

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/19/2023

Event Type  Injury  

Manufacturer Narrative

According to the facility on (b)(6)2023 a piece of mesh from the sterile drape was retained in the patient during surgery, requiring another surgery to remove the foreign body on (b)(6)2023.Per the facility the "mesh tore and was unintentionally retained inside the patient".No additional information is available at this time.The sample was requested 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 (b)(6)2023 a piece of mesh from the sterile drape was retained in the patient during surgery, requiring another surgery to remove the foreign body on (b)(6)2023.

• Type of Device: GYN LAPAROSCOPY PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18680031
• MDR Text Key: 335073357
• Report Number: 1423395-2024-00016
• Device Sequence Number: 1
• Product Code: OHD
• 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: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYNJ38401N
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other