• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CONVATEC LTD AQUACEL BASE; DRESSING,WOUND,HYDROPHILIC Back to Search Results
Model Number 177901
Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the product was cut and caught in seal.Usage of device was unknown.The photographs depicting the issue were received from complainant.
 
Manufacturer Narrative
Device 1 of 5.Complainant country: poland based on the available information, this event is deemed to be a reportable malfunction.Pm logs had been checked and they were all completed with no discrepancies.A batch record review was completed and no discrepancies were found.Aquacel drs 5x5cm (1x10pk) ster ceu was manufactured under sap code 1161262 and manufacturing lot number 0f01132 on 11 june 2020.Lot 0f01132 was sterilised under reference uk32s12446568-1-1 and released on review of results of sterilisation provided by sterilisation company steris.All the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 0f01132.Nine complaints exist for this affected lot registered in database, reported partial cut dressings, product in seal, empty primary packs and short count.The other complaint issues reported for this batch indicated a common failure mode.No photographs were attached to the complaint record initially, but additional images were received upon request for this complaint.Four photographs were received and has been evaluated in accordance with working instructions.The photographs confirmed the expected lot number, product, and the complaint issue where three dressings were identified as trapped in the seal and cut.The images showed the individual sachet numbers 12670, 12671 and 12544 of the affected dressings.2 additional dressing were identified to also have dressing stuck in the seal for this reported batch, with additional sachet numbers reported as 12489 and 12490.A nonconformance was opened for this complaint issue.A data review was raised, but as other complaints and non-conformances had been raised for similar failures on doyen 3, an older investigation was still relevant for this issue and failure mode.The investigation was completed in jan 2021, confirms the most probable causes of open product/product in seal on doyen 3 line.Corrective actions to address the issues identified were implemented in dec 2020 for doyen 3 and further validation activities completed in quarter 4 (q4) 2021.As the affected batch was manufactured in june 2020, this was before the improvements to the line were made.The affected batch is currently held on a stop ship order with the requirement for a rework/reinspection to be completed before returning saleable stock to market.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.Fda registration number reporting site: 1049092 manufacturing site: 1000317571.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AQUACEL BASE
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 Key15333473
MDR Text Key305590175
Report Number1000317571-2022-00145
Device Sequence Number1
Product Code NAC
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number177901
Device Lot Number0F01132
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/03/2022
Initial Date FDA Received09/01/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-