MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN SURGICAL PATTIE; PATTIE, COTTONOID

Catalog 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  

Manufacturer Narrative

Ten unused patties from this lot were returned for eval.A f/u report will be filed upon completion of the eval.

Event Description

Per medwatch report: 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.Note: customer is unsure of the device lot code.Reports it could be et427 or dw526.Vol ref # mw5064153.

• Brand Name: CODMAN SURGICAL PATTIE
• Type of Device: PATTIE, COTTONOID
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount dr.; raynham MA 02767 0350
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC.; 325 paramount dr.; raynham MA 02767 0350
• Manufacturer Contact: matthew king ; 325 paramount dr.; raynham, MA 02767-0350 ; 5088283106
• MDR Report Key: 5885370
• MDR Text Key: 52720614
• Report Number: 1226348-2004-00266
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial

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: Health Professional
• Device Expiration Date: 05/31/2006
• Device Catalogue Number: 80-1400
• Device Lot Number: ET427
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2004
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2004
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2001
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR