MAUDE Adverse Event Report: Covalon Technologies Ltd IV Clear 10x12cm with notch and tape strips; Dressing, Wound, Drug

Model Number	TWBD1014
Medical Device Problem Codes	Material Puncture/Hole (1504); Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Pt arrived with iv clear on and complaints that it appears to be coming apart.Plan to change dressing.Upon opening package, iv clear dressing appears to have very thin areas, almost looks like holes.

• Brand Name: IV Clear 10x12cm with notch and tape strips
• Common Device Name: Dressing, Wound, Drug
• Manufacturer (Section D): Covalon Technologies Ltd; 1200 brickell ave ste 1950 # 1; miami FL 33131
• MDR Report Key: 50752985
• Report Number: 50752985
• Device Sequence Number: 21185890
• Product Code: FRO
• UDI-Device Identifier: 00825439010150
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2026
• Report Date (Section F): 08/04/2026

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 Model Number: TWBD1014
• Device Catalogue Number: TWBD1014
• Device Lot Number: 44673-1-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/14/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2026
• 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
• Date Report Sent to FDA: 08/04/2026