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

Catalog Number 80-1401

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 09/16/2019

Event Type  malfunction  

Event Description

Open a pack of 3/4 x 3/4 surgical patties to sterile field.When counting sponges rn and i counted 10 with the [invalid] and 1 without the [invalid] making the final count 11.The sponges did not come into contact with the pt.Fda safety report id # (b)(4).

• Brand Name: CODMAN SURGICAL PATTIES SPONGES
• Type of Device: NEUROSURGICAL PADDIE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC.
• MDR Report Key: 9098142
• MDR Text Key: 159623892
• Report Number: MW5089923
• 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: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80-1401
• Device Lot Number: J36M93
• 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 Age: 67 YR