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

Catalog Number 80-1403

Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4) upon completion of the investigation a follow up report will be filed.

Event Description

Yesterday in the neuro room they lost a cottonoid, and eventually found it, but in the process of looking for it, they shot a "test" xray to see if the cottoinoid would even show up on xray.It did not.They were using a 1x1 cottonoid for the test, and clinician said you could barely see the line.They showed me again just now in the case we're in, clinician placed a 1x1 cottonoid in the wound and you can't even see it under x-ray.This is a huge concern! we used to be able to see the lines on them much better.

Manufacturer Narrative

Correction: device available for evaluation?, device evaluated by mfr? additional info: device available for evaluation?, date received by mfr, type of report, if follow-up, what type?, device evaluated by mfr and evaluation codes.The customer was contacted regarding product returned; however, the product was not returned for evaluation.As such it is not possible to evaluate the product and determine the root cause of this complaint.Furthermore, the lot number for the subject product was not reported; therefore, the lot history records cannot be reviewed.We will continue to monitor for this or similar complaints for this product code.At this time this complaint is considered to be closed, should the product be returned at a later date this complaint will be re-opened and an investigation will be performed.

• Brand Name: CODMAN SURGICAL PATTIE
• Type of Device: PADDIE, COTTONOID
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5538920
• MDR Text Key: 41579360
• Report Number: 1226348-2016-10250
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK880402
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 80-1403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2016
• 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