MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3W0750 - DUODERM; DRESSING,WOUND,OCCLUSIVE

Model Number 187955

Device Problem Difficult to Remove (1528)

Patient Problems Erythema (1840); Itching Sensation (1943); Pain (1994); Skin Irritation (2076); Swelling (2091); Burning Sensation (2146); Reaction (2414)

Event Date 12/30/2020

Event Type  malfunction  

Manufacturer Narrative

Device 5 of 12.(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.(b)(4).

Event Description

The end user received 3 packs of dressings from the doctor.The end user was prescribed dermovate ointment to be used with dressings on left lower leg, which were to be changed daily.The end user applied 12 dressings on each of the first 12 days of treatment in conjunction with dermovate ointment (1 dressing used every day for 12 days).After 12 days, the area around the lesion being treated became red, irritated, swollen and itchy although the area on which the ointment had been spread was clear.The area that was in contact with the dermovate ointment did not cause a skin reaction.The dressings became more and more difficult to remove without causing pain.Initially, they were quite easy to remove.It was difficult to assess whether the dressings became more sticky, or simply more painful as the area became inflamed.The end user reported the problem to the general physician, who prescribed the treatment initially.The end user was not using any skin preparations other than the dermovate ointment in the center of the area covered by the dressing.The end user did not experience any bleeding and the skin was not broken, although the red area was raised slightly from the surrounding skin.The end user continued applying dermovate cream but three times a day rather than the one prescribed, leaving the area uncovered.The affected area was quite red and itchy.It was not particularly tender, but felt slightly sore.The end user applied dressings every two days, leaving the lesion without a dressing for the second day in each case.The end user now had 15 dressings left.The end user was not normally sensitive to plasters in any form.A photograph depicting the issue was received from the end user.

Event Description

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

Manufacturer Narrative

Correction (g1) - contact office address: dr.(b)(6).Batch record review: lot: 9j01954 was manufactured on 09/15/2019, bodolay pratt c manufacturing line.With a total of (b)(4) market units.Complaint investigator id: (b)(4) performed a batch record review on 16/feb/2021, description duoderm xthin drs 10x10cm (1x10pk) gb, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom and all the tooling information documented was also correct.Sap material: 1052384 and manufacturing order: (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.Returned sample evaluation: there is one photograph associated with this case and no unused return sample was expected.Conclusion summary of the related event: based on the preliminary investigation performed, no issues related to the customer experience were found in the batch record review.The sterilization certificate indicates that the results of the quality tests were satisfactory, and the product received the indicated doses within the precision and accuracy of the dosimetry system employed.In addition, the product was used within its shelf life.Moreover, no significant changes have been made in the process or in the product components that could cause the adverse effects reported by the customer.It is possible that patients have reacted allergic / sensitive to one of the product components (e.G.Pentalyn h).However, the insert information for use (ifu) for duoderm extra thin product specifies that the product ¿should not be used on individuals who are sensitive to or who have had an allergic reaction to the dressing or its components¿.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.

Event Description

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

Manufacturer Narrative

This emdr is being submitted to include the below: h6 - investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions.Correction (g1) - contact office address: (b)(6).Batch record review: lot 9j01954 was manufactured on 09/15/2019, in the bodolay manufacturing line with a total of (b)(4) mkus.Complaint investigator id 6055 performed a batch record review on (b)(6)2021, to verify if all the applicable procedures were followed and no issues were found, all the components for assembly were correct per bom and all the tooling information documented was also correct, sap material id 1052384 and manufacturing order 1492440.No discrepancies related to the issue reported were found.Returned sample evaluation: one (1) photo of the condition reported was received.No unused return samples were expected.Conclusion summary of the related event: based on the results of the preliminary investigation, no harm was reported from any of the complainants, photos were available for evaluation, no samples were available for testing.Based on the evaluated photos, complaint reported had been confirmed.Nevertheless, no additional action is required, due to, according to the preliminary investigation and evaluations performed during the manufacturing process, it was concluded that this defect could not be generated during the manufacturing process.The investigation associated with related event was approved and complete.No additional action is required, and this complaint will be closed.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: 9618003.

• Brand Name: L3W0750 - DUODERM
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 11213882
• MDR Text Key: 228631834
• Report Number: 9618003-2021-00124
• Device Sequence Number: 1
• Product Code: NAD
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 187955
• Device Lot Number: 9J01954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/05/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2019
• 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