MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-KNEE PACK

Catalog Number	DYNJ46384N
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The account reported finding coban adhesive issue, and the reporter stated the product was sticking and not pulling apart easily.A sample was received for investigation; medline received one coban from the customer¿s shoulder pack that was labeled good and one coban that was from the reported pack, reviewed finished good production records, reviewed the finished good pack build, and reviewed trending.Both cobans had no issues with adhesive and no other defects were noted; based on the information provided and with the physical sample received, medline could not confirm the reported issue.No visual defects were observed, medline was unable to confirm a potential root cause with the sample provided, and the supplier quality team will monitor this issue for trending purposes.There were no reports of death, serious injury, medical intervention, or follow up care.This is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.
Event or Problem Description
It was reported that coban component (b)(6) in multiple packs it extremly difficult to get off of the roll.

• Brand Name: MEDLINE
• Common Device Name: DBD-KNEE PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: namirah khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50754766
• Report Number: 1417592-2026-39281
• Device Sequence Number: 15759178
• Product Code: OJH
• UDI-Device Identifier: 40193489937276
• UDI-Public: 40193489937276
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DYNJ46384N
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/24/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown