MAUDE Adverse Event Report: CONVATEC LIMITED AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED; DRESSING, WOUND, DRUG

Model Number 420676

Device Problems Delivered as Unsterile Product (1421); Defective Device (2588); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a malfunction.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).Note: this complaint issue occurred on (2) separate cases.A separate 3500a form has been completed for the known number of affected products associated with this complaint.Not returned to manufacturer.

Event Description

It was reported that when the customer opened the package of aquacel ag dressing, there was red tape sealed into the dressing.The product was not used on a patient.

Manufacturer Narrative

This supplemental is submitted to retract the initial mfr report #1000317571-2016-00068, submitted to the fda on september 2, 2016.Based on further review of the reported complaint by quality, the previously reported complaint issue is considered a non-reportable event.(b)(4).

• Brand Name: AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED
• Type of Device: DRESSING, WOUND, DRUG
• Manufacturer (Section D): CONVATEC LIMITED; 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 ; 3365424681
• MDR Report Key: 5925120
• MDR Text Key: 53831901
• Report Number: 1000317571-2016-00068
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2016
• 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: Unknown
• Patient Sequence Number: 1