MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. SPONGE PATTY- NEURAY SURGICAL PATTIES; NEUROSURGICAL PADDIE

Model Number 8004003

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 10/06/2021

Event Type  malfunction  

Event Description

Right before closing count in operating room, a patty was found with it's [invalid] missing.The patty sponge was there and was intact, but the [invalid] was not attached to it.Fda safety report id# (b)(4).

• Brand Name: SPONGE PATTY- NEURAY SURGICAL PATTIES
• Type of Device: NEUROSURGICAL PADDIE
• Manufacturer (Section D): MEDTRONIC XOMED, INC. ; 6743 southpoint drive n.; FL 32216 0980
• MDR Report Key: 12659692
• MDR Text Key: 277444324
• Report Number: MW5104719
• Device Sequence Number: 1
• Product Code: HBA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8004003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR