MAUDE Adverse Event Report: Centurion Medical Products Medline; SILVER DRIVELINE MANAGEMENT SYSTEM

Catalog Number	EBSI1717
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "the anchor that comes in the kit ripped his skin off.".
Additional Manufacturer Narrative
It was reported that "the anchor that comes in the kit ripped his skin off." per the customer, the "patient stated following instructions when applying item" and said, "when trying to take item off the skin it tends to "[rip]" the skin off when applying the item." the customer also reported that there were no user or patient injuries.There were no reports of death, serious injury, medical intervention, or follow-up care.It has been determined that the event did not involve a death or serious injury; however, it meets the definition of a reportable malfunction, as recurrence of the malfunction could cause or contribute to death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.

• Brand Name: Medline
• Common Device Name: SILVER DRIVELINE MANAGEMENT SYSTEM
• Manufacturer (Section D): Centurion Medical Products; tri-state de mexico; s. de r.l. de c.v.; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50790247
• Report Number: 3004519921-2026-00084
• Device Sequence Number: 21224973
• Product Code: OXQ
• UDI-Device Identifier: 10653160369707
• UDI-Public: 10653160369707
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: EBSI1717
• Device Lot Number: 2026031290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2026
• 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