MAUDE Adverse Event Report: ALBA HEALTH ALBA HEALTH; PRETREATED COTTON STOCKINETTE 3X72IN

Catalog Number 87766

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Customer reported "mold on stockinette." no lot, sample, or picture was provided by complainant.Date of event was unknown and not provided by complainant.

Manufacturer Narrative

The affected stockinette was contained in a convenience kit manufactured by roi cps, llc.No other reports have been received related to contamination on other stockinettes used in the production of convenience kits.The user of the device/complainant did not provide any details related to the event.This mdr report is being filed due to the unknown factors or details related to the event and the source of the alleged contamination identified as "mold" by the user.

• Brand Name: ALBA HEALTH
• Type of Device: PRETREATED COTTON STOCKINETTE 3X72IN
• Manufacturer (Section D): ALBA HEALTH; 425 gateway ave; rockwood TN 37854
• Manufacturer (Section G): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, MO 65738 ; 4176473205
• MDR Report Key: 16263677
• MDR Text Key: 309200555
• Report Number: 3014527682-2023-00001
• Device Sequence Number: 1
• Product Code: FQL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 87766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1