MAUDE Adverse Event Report: CODMAN PATTIES; PADDIE, COTTONOID

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

It has been communicated that the device and/or lot information is not available for evaluation.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.

Event Description

Customer contacted us claiming that a doctor left 2 codman patties in the patient and refused to remove it.Patient is doing okay.As i told you we have a situation where a surgeon has decided to leave 2 surgical patties/cottonoids (ref #80-1400, #80-1403, or #80-1404) in a patient.The procedure was a spine surgery and occurred in november, if i remember correctly.(at this time i do not have the actual date of the occurrence.) we are also acutely aware of the warning stated on the package insert about not leaving patties or strips in situ and that failure to remove them may result in a foreign body reaction.

• Brand Name: CODMAN PATTIES
• Type of Device: PADDIE, COTTONOID
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5351296
• MDR Text Key: 35277224
• Report Number: 1226348-2016-10032
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention