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

Catalog Number	DYNJ38849D
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/14/2019
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: GAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE ONLY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; norfield IL 60093
• MDR Report Key: 8270892
• Report Number: MW5083299
• Device Sequence Number: 1617090
• Product Code: GDY
• UDI-Device Identifier: 10889942966998
• UDI-Public: 1088994 2966998
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Weight: 96