MAUDE Adverse Event Report: WOLFE TORY MEDICAL INC. MAD NASAL WITHOUT SYRINGE; MUCOSAL ATOMIZATION DEVICE

Catalog Number MAD300

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 12/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the device involved in this complaint has been returned to the manufacturer.However, the investigation into said device is still in progress at the time of this report.

Event Description

Customer complaint alleges that "the mad300 packaging was missing the variable lot printing".Alleged issue was detected during incoming inspection, prior to patient involvement.

Manufacturer Narrative

(b)(4).The sample was not returned for evaluation; however, the customer returned a photo.The photo confirmed that the pouch has incomplete printing.A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.Based on the investigation performed, the reported complaint was confirmed.The product was placed on ship hold and a capa was opened to address this issue.

Event Description

Customer complaint alleges that "the mad300 packaging was missing the variable lot printing".Alleged issue was detected during incoming inspection, prior to patient involvement.

• Brand Name: MAD NASAL WITHOUT SYRINGE
• Type of Device: MUCOSAL ATOMIZATION DEVICE
• Manufacturer (Section D): WOLFE TORY MEDICAL INC.; salt lake city UT
• Manufacturer (Section G): WOLFE TORY MEDICAL INC.; 79w 4500 s suite 18; salt lake city UT 84107
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6253794
• MDR Text Key: 65357712
• Report Number: 1722554-2017-00001
• Device Sequence Number: 1
• Product Code: CCQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/12/2019
• Device Catalogue Number: MAD300
• Device Lot Number: 160518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: No
• 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