MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; SHOULDER ARTHROSCOPY SAH

Catalog Number	DYNJT5308
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	04/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2026 two skin tears from the drape were noted on the "right pec, above the nipple" following a "shoulder arthroscopy." per the facility, "they came to the conclusion that it's user error as no other location is reporting problems with [the] drape." 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.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 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 or Problem Description
According to the customer, on (b)(6) 2026 two skin tears from the drape were noted on the "right pec, above the nipple" following a "shoulder arthroscopy." per the facility, "they came to the conclusion that it's user error as no other location is reporting problems with [the] drape.".

• Brand Name: MEDLINE
• Common Device Name: SHOULDER ARTHROSCOPY SAH
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 25193436
• Report Number: 1423395-2026-00166
• Device Sequence Number: 21073710
• Product Code: LRO
• UDI-Device Identifier: 10198459471810
• UDI-Public: 10198459471810
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJT5308
• Device Lot Number: 25HBN486
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown