MAUDE Adverse Event Report: CONVATEC LIMITED KALTOSTAT CALCIUM ALGINATE WOUND DRESSING; DRESSING, WOUND, HYDROPHILIC

Model Number 168210

Device Problems Delivered as Unsterile Product (1421); Shipping Damage or Problem (1570); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 08/19/2016

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).

Event Description

It was reported the dressing was press-fit together with the primary pack.This was noted during inspection and the product was not used on a patient.No further details have been provided.

Manufacturer Narrative

A batch record review was performed and indicates that all required specification was met and documented within the batch records.There were no discrepancies noted related to the reported complaint issue.A photograph was available and a dressing trapped in seal was evident.A nonconformance (nc) was initiated for this previously and the investigation has been completed and is closed; therefore, this complaint can be closed.This issue will be monitored through the post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

Received product sample and was confirmed to be a convatec product.The product was unused and did appear to be stuck to primary pack based on visual inspection.Product was forwarded to original equipment manufacturer for evaluation.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

• Brand Name: KALTOSTAT CALCIUM ALGINATE WOUND DRESSING
• Type of Device: DRESSING, WOUND, HYDROPHILIC
• Manufacturer (Section D): CONVATEC LIMITED; first avenue; deeside industrical park; deeside, flinshire CH52N U; UK CH52NU
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5940775
• MDR Text Key: 54403198
• Report Number: 1000317571-2016-00070
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/01/2018
• Device Model Number: 168210
• Device Lot Number: 5G03591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2016
• Date Manufacturer Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2015
• 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