MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. COTTON BALL, LARGE 1", DOUBLE-STRUNG 5/PK 50 PKS/CS

Model Number 30-034

Device Problem Material Disintegration (1177)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

Root cause has yet to be determined.This investigation is ongoing and a follow up report will be submitted once additional information is received.

Event Description

The cotton balls fell apart during neurosurgery as soon as any blood hit them when they were placed in the brain.

Manufacturer Narrative

Root cause has yet to be determined.This investigation is ongoing and a follow up report will be submitted once additional information is received.

Event Description

The cotton balls fell apart during neurosurgery as soon as any blood hit them when they were placed in the brain.

Manufacturer Narrative

This product had a complaint/sales ratio 0.001342 = 0.134% from november 2019 to november 2021 with 1 complaint reported during this time frame.The one reported complaint did not have the same failure code as the reported event.The work order and inventory was checked and showed no discrepancies.No patient impact was reported and no additional information was received from the reporting hospital.A scar was completed and no root cause could be determined as the unit was not returned for evaluation.The cotton balls were converted from cotton fibers.As a natural material, cotton tends to expand or stretch over time and were not tested to be used in neurosurgery applications and is not indicated to be used as reported, so this was off label use.No further information is available at this time.A follow up report will be submitted if additional information is received.

• Brand Name: COTTON BALL, LARGE 1", DOUBLE-STRUNG 5/PK 50 PKS/CS
• Type of Device: COTTON BALL
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 hwy 33 south; new tazewell TN 37825
• Manufacturer Contact: mary catherine reeves ; 200 debusk lane; powell, TN 37849
• MDR Report Key: 13024858
• MDR Text Key: 286023211
• Report Number: 1060680-2021-00007
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 30-034
• Device Catalogue Number: 30-034
• Device Lot Number: 54487272
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other