MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP FHSH LAP CHOLE PACK-LF

Catalog Number DYNJ61123A

Device Problem Material Frayed (1262)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/01/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that the 4x4 x-ray gauze sponges in the lap chole pack frayed in the pack.The pieces of fibers were found and surgically removed from the patient.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The customer did return photos and samples for evaluation and the gauze was noted to be completely unfolded during use and inspection.According to the manufacturer it is recommended that gauze not be unfolded more than once.Due to the reported incident and 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

It was reported that the 4x4 x-ray gauze sponges in the lap chole pack frayed in the pack.The pieces of fibers were found and surgically removed from the patient.

• Brand Name: FHSH LAP CHOLE PACK-LF
• Type of Device: FHSH LAP CHOLE PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 14138338
• MDR Text Key: 289486732
• Report Number: 1423395-2022-00013
• Device Sequence Number: 1
• Product Code: FDE
• 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: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ61123A
• Device Lot Number: 21GMA078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention