MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. CURAD TELFA NON-ADHERENT PAD; DRESSING, WOUND, OCCLUSIVE

Catalog Number NON25720

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2019

Event Type  malfunction  

Event Description

Telfa opened to sterile field and black spot noticed on sterile item.Item removed from sterile field.Fda safety report id# (b)(4).

• Brand Name: CURAD TELFA NON-ADHERENT PAD
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; mundelein IL 60060
• MDR Report Key: 8683101
• MDR Text Key: 147594633
• Report Number: MW5087206
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NON25720
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 64