MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS; DRESSING,WOUND,HYDROPHILIC

Model Number 420669

Device Problem Difficult to Remove (1528)

Patient Problem Skin Inflammation (2443)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.Additional information has been requested, however to date no additional information has been received.Should additional information become available, a follow-up report will be submitted.

Event Description

It was reported the dressing was difficult to remove.The reporter described the dressing as having ¿too much elasticity (as if it was gum).¿ it was further reported that the patient experienced what appears to be dermatitis on the skin after removing the dressing.No additional information could be obtained.No photo was provided.

Event Description

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

Manufacturer Narrative

No samples or photos were received for analysis and investigation; for that reason, the malfunction reported by the customer could not be confirmed.In addition, a complaint search for lot 7k06407 and malfunction code for adhesive dressing requires excessive force for removal from skin (i.E.Difficult to remove) was carried out and as a result, no additional complaint was found; therefore, no trend is observed.As per complaint manufacturing investigation procedure work instructions (wi), version 4.0, it is not required to open a nonconformance report (ncr) for this type of complaints which were not confirmed.Lot 7k06407 was manufactured on 10 november 2017, scd packaging line, with a total of (b)(4) units.Complaint investigator performed a batch record review on 28 september 2020, description aquacel scd drs 9x30cm (1x10pk) eur to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bill of materials (bom) and all the tooling information documented was also correct.System application product (sap) material identification 1704503 and manufacturing order 1364785.The batch record review supports that there were no discrepancies related to the issue reported.No additional action is required, and this complaint will be closed.This issue will be monitored through the post market product monitoring review process.No additional information has been received.Should additional information become available, a follow-up report will be submitted.Reporting site: (b)(4).Manufacturing site: (b)(4).

• Brand Name: AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS
• Type of Device: DRESSING,WOUND,HYDROPHILIC
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• MDR Report Key: 7947158
• MDR Text Key: 123081090
• Report Number: 9618003-2018-02006
• 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,health professional,o
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2019
• Device Model Number: 420669
• Device Lot Number: 7K06407
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1