MAUDE Adverse Event Report: SECUREMENTS; TAPE AND BANDAGE, ADHESIVE

Model Number 680M

Device Problems Unsealed Device Packaging (1444); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

The distributor reported the primary package was not sealed.The device was not used.No further information or photographs were provided.

Manufacturer Narrative

Corrected device manufacturing date a batch record review indicates no discrepancies.Machine logs have been checked and there are no discrepancies.Preventive maintenance logs have been checked and all preventive maintenance were completed.No photograph or sample has been received in relation to this complaint.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.

• Brand Name: SECUREMENTS
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409
• MDR Report Key: 7489565
• MDR Text Key: 107469338
• Report Number: 1000317571-2018-00055
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 10/01/2019
• Device Model Number: 680M
• Device Lot Number: 6K02756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/03/2018
• 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: N
• Patient Sequence Number: 1