MAUDE Adverse Event Report: CONVATEC LTD AQUACEL FOAM; DRESSING,WOUND,HYDROPHILIC

Model Number 420619

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2022

Event Type  malfunction  

Event Description

It was reported that one of the ten pieces was broken and could not be used.No photo is available at this time.

Manufacturer Narrative

Complainant city: (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.Fda registration number reporting site: (b)(4).

Event Description

To date no additional patient or event details have been received.

Manufacturer Narrative

A batch record review was completed and no discrepancies were found.Aquacel foam adh 12.5x12.5(1x10) nai was manufactured under system application product (sap) code 1703936 and manufacturing lot number 2a03216 on 22 january 2022.Lot 2a03216 was sterilised under order (b)(4) and released on review of results of sterilisation provided by sterilisation company steris.All of the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 2a03216.This is the only complaint within database against this lot.No photographs were received for this issue for evaluation in accordance with work instructions (wis).No samples were available for this complaint, and therefore it was not possible to confirm the complaint.As no photographs or samples were available for this complaint issue, it was not possible to raise a nonconformance or investigate the issue.A batch record review was completed, with no discrepancies found and no indications of open seals being identified within the batch during manufacture.This issue will be monitored through the post market product monitoring review process, standard operating procedure (sop).To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092, manufacturing site: 1000317571.

• Brand Name: AQUACEL FOAM
• Type of Device: DRESSING,WOUND,HYDROPHILIC
• 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: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 15787913
• MDR Text Key: 307594563
• Report Number: 1000317571-2022-00339
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 420619
• Device Catalogue Number: 420619
• Device Lot Number: 2A03216
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2022
• 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