MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; SKIN AFFIX SURG ADHESIVE 72/CS 0.55ML

Model Number MSC091040

Device Problem Material Integrity Problem (2978)

Patient Problem Laceration(s) (1946)

Event Date 11/30/2022

Event Type  Injury  

Manufacturer Narrative

According to the facility on (b)(6) 2022 after a surgical case was complete "the scrub tech activated skinaffix by squeezing it and a piece of glass came through the plastic outer coating and stuck in their right thumb".Per the facility they removed their gloves, washed their hands, and cleaned the area with alcohol.Per the facility the staff member went to the emergency room where "the wound was explored, sutures were placed, and antibiotics and pain meds were given".Per the facility the staff member is reported to be doing "fine".A photo was provided for evaluation, however, a definitive root cause could not be determined.No additional information is available at this time.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) 2022 after a surgical case was complete "the scrub tech activated skinaffix by squeezing it and a piece of glass came through the plastic outer coating and stuck in their right thumb".

• Brand Name: Medline
• Type of Device: SKIN AFFIX SURG ADHESIVE 72/CS 0.55ML
• 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: 16130987
• MDR Text Key: 307012062
• Report Number: 1417592-2023-00021
• Device Sequence Number: 1
• Product Code: MPN
• UDI-Device Identifier: 10884389953044
• UDI-Public: 10884389953044
• 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: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSC091040
• Device Catalogue Number: MSC091040
• Device Lot Number: P00225542
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/29/2022
• 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): Required Intervention