MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; LAP SPONGE IN C-SECTION PACK

Catalog Number DYNJ17488G

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that a lap sponge was retained in a patient.According to the reporting facility, when the unknown cesarean section (c-section) tray was opened for an emergency c-section, it was identified to be missing one (1) lap sponge during counting.When this was identified, an unknown number of additional lap sponge packages were opened for use.The emergency c-section was completed with lap sponges from the unknown c-section tray and the unknown lap sponge packages.No information was provided to the manufacturer regarding the total lap sponge count prior to the start of the procedure and at the end of the procedure.Reportedly, on post-operative day three, the patient complained of abdominal pain.A ct scan was performed and a retained lap sponge was reportedly identified.The patient required a retrieval procedure.No further incident was reported to the manufacturer.No product information was provided to the manufacturer.No sample was returned for evaluation.A root cause for the reported incident could not be determined.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that a lap sponge was retained and the patient required an additional retrieval procedure.

Manufacturer Narrative

Additional information was received from the reporting facility.The manufacturer was provided with information on the cesarean section tray that was utilized.If additional relevant information becomes available another supplemental medwatch will be filed.

• Type of Device: LAP SPONGE IN C-SECTION PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8680426
• MDR Text Key: 147441875
• Report Number: 1423395-2019-00020
• Device Sequence Number: 1
• Product Code: OHM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ17488G
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 06/03/2019
• Supplement Dates FDA Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR