MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING; DRESSING,WOUND,OCCLUSIVE

Model Number 187955

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Wheal(s) (2241)

Event Date 01/08/2020

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

End user reports she had placed the dressing over a scar on her right knee at approximately 10 pm.She is six weeks post op from a knee replacement, and her doctor approved the dressing be placed on the scar.Approximately five hours later, at 3 am, she awoke with itching of both arms and under her breasts.She noted hives on both arms.She states her knee felt hot under the dressing.She removed the dressing and said her skin was clear and intact under the dressing.She took a prescription allergy pill, hydroxyzine hydrogen chloride (hcl), which she had on hand for her seasonal allergies and was not prescribed for this event.She removed and discontinued the product.She went back to bed, and when she woke up, she felt much better.She reports that all the symptoms resolved, except she still had some slight itching by her elbows and under her breasts.

Manufacturer Narrative

Correction (g1) - contact office address: (b)(6).Batch record review: lot 9a00460y was manufactured on 01/10/2018, bodolay pratt c manufacturing line.With a total of 16,000 market units.Complaint investigator id 6055 performed a batch record review on 16/feb/2021, description duoderm xthin drs 10x10cm (1x10pk) nai, 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 1704768 and manufacturing order 1441755.The batch record review supports that there were no discrepancies related to the issue reported.Returned sample evaluation: there is no 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.

• Brand Name: DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• MDR Report Key: 9602962
• MDR Text Key: 175444965
• Report Number: 9618003-2020-00423
• 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: consumer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/08/2023
• Device Model Number: 187955
• Device Lot Number: 9A00460Y
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1