MAUDE Adverse Event Report: CONVATEC LTD 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 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.A batch record review shows that there were seal issues during the manufacture of the batch and that a process technician was called to the line to fix the problem.Two (2) photographs have been received for this complaint, which were evaluated.One (1) of the photographs confirms the lot number and the other shows the open seal.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.(b)(4).

Event Description

It was reported the package seal was ¿not well¿ and the product was received in a non-sterile state.The product was not used.A photograph depicting the reported issue (open weld) was provided.No further information was provided.

• Brand Name: SECUREMENTS
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer (Section G): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409
• MDR Report Key: 7533401
• MDR Text Key: 108998122
• Report Number: 1000317571-2018-00056
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 03/01/2019
• Device Model Number: 680M
• Device Lot Number: 6C02728
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2018
• 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