MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC. CODMAN SURGICAL PATTIES COTTONOID, PLEDGET; NEUROSURGICAL PADDIE

Catalog Number 80/1407

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/20/2019

Event Type  Injury  

Event Description

When removing ½¿ x 3¿ cottonoid sponge from left nasal cavity, the 9 inch [invalid] broke off, leaving cottonoid temporarily retained.Missing surgical item radiologic film verified retained foreign body in posterior left nasal cavity.Surgeon able to remove.Fda safety report id # (b)(4).

• Brand Name: CODMAN SURGICAL PATTIES COTTONOID, PLEDGET
• Type of Device: NEUROSURGICAL PADDIE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC.; rayham MA 02767
• MDR Report Key: 9437675
• MDR Text Key: 170423497
• Report Number: MW5091518
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80/1407
• Device Lot Number: J4221P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Weight: 84