MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. PROCTO SWAB; APPLICATOR, ABSORBENT TIPPED, NON-STERILE

Catalog Number 31-999

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 01/18/2021

Event Type  malfunction  

Event Description

Cotton swab end of the 6-inch procto swab came off of the swab while being used in patient's vagina.Surgeon retrieved cotton tip/end, and searched vagina for additional cotton.Surg tech inspected both pieces of procto swab to ensure that all pieces of product were removed from body.Procto swab pieces were removed from sterile field and placed in biohazard bag.Packaging was placed in outer pocket of bag.

• Brand Name: PROCTO SWAB
• Type of Device: APPLICATOR, ABSORBENT TIPPED, NON-STERILE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 11235850
• MDR Text Key: 228886922
• Report Number: 11235850
• Device Sequence Number: 1
• Product Code: KXF
• 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: 01/20/2021

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 Operator: Health Professional
• Device Catalogue Number: 31-999
• Device Lot Number: 52161375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA