MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. RAYTEC GAUZE BASIN SET ; GAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE ONLY

Catalog Number DYNJ38849D

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/14/2019

Event Type  Injury  

Event Description

During a hydrocelectomy/spermatocelectomy, the surgeon was using a raytec sponge, it shredded and a long piece separated from the sponge and was found later in the wound.Removed before closure.

• Brand Name: RAYTEC GAUZE BASIN SET
• Type of Device: GAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE ONLY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; norfield IL 60093
• MDR Report Key: 8270892
• MDR Text Key: 134019411
• Report Number: MW5083299
• Device Sequence Number: 1
• Product Code: GDY
• UDI-Device Identifier: 10889942966998
• UDI-Public: 1088994 2966998
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/18/2019

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: DYNJ38849D
• Device Lot Number: 18JB1801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 96