MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC CODMAN SURGICAL PATTIES; COTTONOIDS

Model Number 80-1400

Device Problems Failure to Sense (1559); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2004

Event Type  malfunction  

Event Description

During spinal surgery for decompression and fusion, it was noted that the cottonoids that were in use were not showing up on x-ray.Seven cottonoids in the spinal wound were not visible on fluoroscopy.Cottonoids that were removed from the wound and placed in a kidney basin were visible on fluoroscopy.Mfr ref #: (b)(4).

• Brand Name: CODMAN SURGICAL PATTIES
• Type of Device: COTTONOIDS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC; raynham MA
• MDR Report Key: 5885354
• MDR Text Key: 52442717
• Report Number: MW5064153
• 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: 08/05/2004

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 80-1400
• Device Catalogue Number: 245-404
• Device Lot Number: ET427 DW526
• Other Device ID Number: 1/2"X1/2"
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR