MAUDE Adverse Event Report: MEDLINES INDUSTRIES STERILE X-RAY DETECTABLE PEANUT SPONGES / GAUZE

Catalog Number	571757
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
During an anterior cervical discectomy c4-c5 and c5-c6, physician was using the medline cherry dissector sponges and according to the physician, were "falling apart" during the dissection.The physician's concern is two-fold.One, he did not want any fragments from the sponge left in the spinal canal and secondly, since the cherry sponges needed to be exchanged more often, the procedure and anesthesia time could be longer.

• Brand Name: STERILE X-RAY DETECTABLE PEANUT SPONGES / GAUZE
• Common Device Name: PEANUT SPONGES / GAUZE
• Manufacturer (Section D): MEDLINES INDUSTRIES; mundelein IL 60060
• MDR Report Key: 6683895
• Report Number: MW5070752
• Device Sequence Number: 162383
• Product Code: GDY
• UDI-Device Identifier: 20884389106294
• UDI-Public: 20884389106294
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/29/2017

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: 571757
• Device Lot Number: 6051611104
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR