MAUDE Adverse Event Report: DERMA SCIENCES, INC. UNKNOWN DUPAQUE XRAY DET SPONGE; SPONGES

Catalog Number XXX-DUPAQUE SPONGE

Device Problems Material Disintegration (1177); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported fibers from the sponges were found in patient's wound.No patient consequence, the fibers were removed from the wound and the nurse's table.

Manufacturer Narrative

Updated fields: d9, g3, g6, h2, h3, h6, h10.The gauze sponges, sterile were not returned for evaluation (as per customer, product not available) and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.This is 100% cotton gauze, not non woven product; therefore, minimal amount of lint is expected; however, it is unknown what fibers the end user complained on as no photo or product returned.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: UNKNOWN DUPAQUE XRAY DET SPONGE
• Type of Device: SPONGES
• Manufacturer (Section D): DERMA SCIENCES, INC.; 104 shorting road; 104 shorting road; toronto, ontario M1S 3 S4; CA M1S 3S4
• Manufacturer (Section G): DERMA SCIENCES, INC.; 104 shorting road; toronto, ontario M1S 3 S4; CA M1S 3S4
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15461695
• MDR Text Key: 302180910
• Report Number: 9680091-2022-00013
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XXX-DUPAQUE SPONGE
• Device Lot Number: 79533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1