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

Model Number 187658

Device Problem Difficult to Remove (1528)

Patient Problems Exposure to Body Fluids (1745); Irritation (1941); Pain (1994); Tissue Damage (2104); Discomfort (2330); Skin Tears (2516)

Event Date 05/30/2020

Event Type  malfunction  

Manufacturer Narrative

Device 1 of 1.(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

It was reported the end user had a panniculectomy procedure performed on (b)(6) 2017.Due to an irritation sustained recently at the waistline from wearing pants, the end user states his doctor's office recommended and provided the duoderm dressing to help reduce the irritation.The end user states he placed the dressing on the irritation area on saturday morning (b)(6) 2020, and during the process of removing the dressing on saturday afternoon the adhesive was way too powerful and resulted in tearing my skin and pulling out the pubic hairs located in that region.It appears to be a huge excoriation of that region as well as skin tore off, leaving an open area along with bruising resulting in severe pain and discomfort.End user reports he contacted his doctor's office and provided both a letter and photos of the irritated area.He was advised to discontinue using the dressing however; no medical treatment was provided.Photograph¿s were provided by the complainant of the irritated area.The end user stated that the area was now healing.

Manufacturer Narrative

On (b)(6)2020 , a query was run in the complaint handling system, for adhesive dressing requires excessive force for removal from skin (i.E.Difficult to remove).A photo was received by the customer, however, there is not evidence to demonstrated that the product was defective as the picture only shows the user reported condition.The following complaints investigation were reported from (b)(6)2020.On (b)(6)2020 , complaints investigator ran a query in the complaint handling system looking for any nonconformance/capa (s) associated to ¿duoderm adhesive result in skin tear¿ for lots number listed in table number a and as result, no nonconformance/capa (s) were generated during the manufacturing process of the referenced lots.On(b)(6)2020 , complaints investigator ran a query in the complaint handling system, looking for customers reporting complaints associated to ¿duoderm adhesive result in skin tear¿ for lot number reported and as result, one (1) complaints were found for lot referenced for the reported malfunction code.On (b)(6)2020 , a batch record review was performed by complaint investigator , for lot 9d01314y manufactured on april 07, 2019, component (1704759- duoderm cgf drs 10x10cm (1x20pk) nai for the bulk manufacturing process used the lot number 9d01315 , were used the dressing component 1003374a1- dressing cgf w/hm w/pet 10x10cm, manufactured in the elc #11, with a quantity of 60,72, manufactured on date april 06, 2019.A revision was conducted in this line (elc #11) to review the testing performed that is as follow: all the test are performed following the instruction of the process instructions.The rolling ball, adhesive test per testing method (tm), strip to strip, t-peel, visual inspection per testing method.The overall thickness and mass thickness also for testing method (tm), the testing method: determination of bond strength, every ½ hour and documented in the batch record (br).The bulk lots for the mass formulation are as follows: 9c0275105, 9c0274110, 9c0274201, 9c0274204, 9c0275002, 9c0274910, 9b0068601,9c0274305.Description mass 177a, machine workcentre amk mixer large #3 (mixer 7).In this line quality assurance performed a visual inspection every two (2) hour and documented the results in the applicable annexes from dominican republic standard operating procedures (dr-sop) with satisfactory results, no non -conformance (nc) or discrepancies were noticed during this batch records review.The assembly process for the involved material 1704759, lot 9d01314y, as well as the documented instruction were reviewed along with the process team, looking for any points were the product could be affected and cause this type of defects; as a result, the line was performing as intended since all steps were executed according to the specifications.In addition, there have been no changes to the mass formulation from 2019 to date.There are no units available from lot 9d01314y in the distribution centers to request samples for further analysis.Based on the above we concluded that there is no potential cause related to the plant manufacturing 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.

Event Description

Additional information was received reporting that customer care spoke with the complainant and he provided the following information.The dressing was provided by his dermatologist to cover fragile scar tissue on his abdomen from a previous surgery, where his belt rubs the area.The dressing had been applied on the morning of (b)(6)2020 , and a few hours later, the upper edge of the dressing began curling away from his skin, so he removed the dressing by "grabbing the edge and yanking it off." he did not use a taffy-pull technique or any adhesive remover.He stated ¿his dermatologist gave him the dressing without any outer package or instructions for use.There was no bleeding upon removal.He is currently applying vaseline intensive care topical lotion to the area and wearing lightweight clothing to minimize friction to the area.¿ he was seen by his primary care doctor this morning who looked at the area but did not receive any further instructions or prescriptions.

• 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: 10164235
• MDR Text Key: 195728683
• Report Number: 9618003-2020-12072
• 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
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2024
• Device Model Number: 187658
• Device Lot Number: 9D01314Y
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THERAPY FOR DVT (TAKEN TWICE A DAY BY MOUTH)
• Patient Age: 62 YR