MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-HM C SECTION CDS

Catalog Number	HM180B
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the dressings appear to look the same, but when removing them from the patient the adhesive does not come off well.The absorbent part will come off, but it leaves behind the adhesive edges.
Additional Manufacturer Narrative
The account reported an adhesive issue with the dressing, and the customer reported that the absorbent part will come off, but it leaves behind the adhesive edges.No sample or photo was received for investigation; the finished good production record was unable to be reviewed due to no lot number being provided, and the finished good pack build noted that the pack assembly instructions called for the dressing component to be utilized within the pack.The reported issue was an unconfirmed defect, and with the information provided medline was unable to confirm the root cause of the issue.A risk assessment was completed and the incident was found to be acceptable; 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.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 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.

• Brand Name: MEDLINE
• Common Device Name: DBD-HM C SECTION CDS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: camilla allen ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50275765
• Report Number: 1417592-2026-17912
• Device Sequence Number: 13356899
• Product Code: OHM
• UDI-Device Identifier: 40193489317368
• UDI-Public: 40193489317368
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 08/17/2026

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: HM180B
• Device Lot Number: UNK PDM
• Was Device Available for Evaluation?: Yes
• 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: 03/17/2023
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown