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

Model Number 187955

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device 2 of 2.Complainant city: (b)(6).Complainant state/province: (b)(6).Patient country: (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 dressing was difficult to remove two days after application.¿ no harm was reported.Photographs depicting the reported complaint issue were provided by the complainant.

Manufacturer Narrative

Historical complaints review: on 22 mar 2021, a query in trackwise 8.7 was ran in order to verify the complaints reported for the lots numbers involved and as result, no additional complaints were reported.Historical nonconformance review: on 22 mar 2021, a query in trackwise 8.7 was ran looking for any nonconformance / capa (s) associated to the failure mode ¿difficult to remove dressing from skin¿ for the lots numbers involved and as result, no nonconformance / capa (s) for these failure mode were generated during the manufacturing process of the referenced lots.Batch record revision results: on 22 mar 2021, a batch record review was performed for bulk lots numbers in the table #2, were manufactured in the elc #10, elc #11.A revision was conducted and review the testing performed that is as follow: all the test are performed following process instructions pi31-103 version 3.0 to 11.0 -for elc #10 and pi31-141 revision 1.0 to 2.0.Elc #11.The rolling ball, adhesive test per tm-011, strip to strip, t-peel, visual inspection per tm-017.The overall thickness and mass thickness also for tm-011, the tm-085: determination of bond strength, every ½ hour and documented in the br31-14, version 1.0.The bulk lots were manufactured following the applicable procedures, all machine and testing parameters were in accordance with the applicable procedures and specifications pi22-084 short cycle amk mixing 1002207 177-a (work center 105) version 7.0.In this line qa performed a visual inspection every two (2) hour and documented the results in the applicable annexes from dr-sop-0063, version 20.0.With satisfactory results, no nc or discrepancies were noticed during this batch records review.According to the instruction for used corresponding to the lots reported by the customer: removing the dressing: press down on the skin and carefully lift and edge of the dressing.Continue around until all edges are free.Repeat cleansing procedures.It is unneccessary to remove all residual dressing material from the surrounding skin.Leave the dressing in place, (not more than 7 days) unless it is uncomfortable, leaking, or there are clinical signs of infection.According to the description of the defect reported by the client, some did not report harm, others reported harm with a dressing duration of 1 to 12 days.They do not describe the method of cleansing the skin.Process description: a revision of the assembly process described in the applicable process instructions (see graph above for reference) were performed in order to determine in which part of the process the reported defect can be generated.Process summary: pi31-103 process instructions for elc 10, 6.3 process summary: (dressing duoderm® extra thin): duoderm® extra thin: 177-a mass that has aged not less than 3 hours since discharge from mixer is placed into the extruder hopper where it is fed to the extruder by the combined actions of two feed rolls and the extruder screw.Roped or log feed stock may be used.The mass is conveyed, compressed, heated, and formed into an adhesive sheet by the actions of the extruder screw, barrel, and die.Once extruded, the mass is calendered to specified thickness and laminated with a layer of medifilm coated paper (top) and a layer of srp.A release liner is added during calendering to create an easy peel tab in the final product.The four layers - paper, mass, release liner, and medifilm -- are drawn through a rotary die and cut to the proper dimension.The completed dressings are inspected and stacked onto trays to be placed on a bulk storage rack to await the next processing step.Process summary: mixer, the aspiration filter and nitrogen generation systems must be operating before the process can begin.All components must be weighed before beginning the actual mixing process.Components are added as specified to amk sigma blade kneader-extruder m07 (work center17001105), heated to a specific temperature, and kneaded for a prescribed length of time.The styrene-isoprene-styrene (sis) component is pre-processed in an extruder prior to addition to the mixer.The compounded mass is discharged through the extruder at the base of the mixer and cut into loaves.The loaves are placed onto racks of trays lines with silicone release paper until delivery to the next processing step.Risk evaluation: the reported condition is wnd-pmc03.08 adhesive dressing requires excessive force for removal from skin (i.E.Difficult to remove).Some harm was reported for the complainants reported.As per ¿wi-0461 phri-002-wnd¿ version 1.0, severity reported for those cases is low.The highest actual severity reported has been hc5.3 infection.The severity for this pmc remains unchanged based on the potential for recurrence.This malfunction will not be reported and will be continuously monitored and reviewed for any changes in the observed actual severity.Conclusions: based on the results of the preliminary investigation, some harm was reported from the complainants, photos is available for evaluation, no samples are available for testing.Based on the evaluated photos, complaint reported have 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.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
• 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: 10520970
• MDR Text Key: 209561708
• Report Number: 9618003-2020-13697
• 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,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 187955
• Device Lot Number: 9E03545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1