MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; APPLICATOR,COTTON-TIP,PLASTIC,6,STERILE

Catalog Number MDS202095H

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/08/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, on (b)(6) 2023 when using the cotton applicator to pack a wound the tip "dislodged in the tunnel" of the wound.The customer reported that the tip was retrieved with "irrigation and packing removal" and the wound care was able to be completed using a different product.The customer reported the patient is "stable".Sample requested for return evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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 customer, on (b)(6) 2023 when using the cotton applicator to pack a wound the tip "dislodged in the tunnel" of the wound.

Manufacturer Narrative

Update h6: investigation conclusions.

• Type of Device: APPLICATOR,COTTON-TIP,PLASTIC,6,STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18297385
• MDR Text Key: 330115517
• Report Number: 1417592-2023-00493
• Device Sequence Number: 1
• Product Code: KXG
• 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,Followup,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MDS202095H
• Device Lot Number: 2952211004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other