MAUDE Adverse Event Report: ALLCARE, INC. OR STERILE TOWEL; ACCESSORY, SURGICAL APPAREL

Lot Number 11RI14

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 03/01/2019

Event Type  No Answer Provided  

Event Description

There was excessive lint coming off of the sterile towels.The surgical site had to be washed off and re-prepped.This has been investigated by our infection prevention team.

• Brand Name: OR STERILE TOWEL
• Type of Device: ACCESSORY, SURGICAL APPAREL
• Manufacturer (Section D): ALLCARE, INC.; 2580 foxfield rd ste 101; st charles IL 60174
• MDR Report Key: 8439290
• MDR Text Key: 139421923
• Report Number: 8439290
• Device Sequence Number: 1
• Product Code: LYU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 11RI14
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2019
• Type of Device Usage: N
• Patient Sequence Number: 1