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

Model Number 420061

Device Problem Delamination (2904)

Patient Problems Tissue Damage (2104); Ulceration (2116)

Event Date 11/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Based on the available information, this event is deemed to be a serious injury.  to date, three attempts for additional information has been requested and for the translation of information reported, however 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 that while the end user was in the hospital, duoderm extra thin 12,5 x 12, 5 was placed on thursday, (b)(6) on the end user's sacrum region as a "prevention of bedsore".On (b)(6) upon removal of the dressing by the nurse, " the mince plate posed on the right buttock as no improvement.When removing the plate, the outer transparent film is detached leaving all the hydro colloid paste on the skin.It's impossible to remove it from the skin.Cleaning with a washcloth but only a small part is removed.Modification of the protocol by bepanthen.But there is still dough.Try complete retreat of the gum protocol bepanthen, decubitus, mattress with air." the medical team made the decision to change the protocol.On (b)(6) the service department confirmed the event.Tissue damage in the form of an ulcer was reported after removing the dressing.Additional information regarding the ulcer was provided that stated, "the ulcer wasn't present before application of the duoderm.It is in removing the duoderm that the lesion appeared." the ulcer was reported to be a "stage 3 ulceration".The dressing was removed ¿according to good use of the product according to the recommendations made by the laboratory.¿.

Manufacturer Narrative

This supplemental report is being submitted as a retraction as it was additionally reported by the complainant that the wound that has been created is more like a dermabrasion based on the hospital staging scale as it was not deep.Therefore, based on this information this is considered to be a non-reportable event.It was further reported that, ¿the patient was hospitalized for hip replacement surgery and the duoderm extra-thin was placed on healthy skin postoperatively on (b)(6) 2017 in pu prevention because due to the patient condition not stabilized.The patient was probed and placed on an air mattress.The nurse observed the dressing delamination during the night from (b)(6) 2017.She removed easily the polyurethane film, external layer, but, the internal hydrocolloid layer was stuck to the patient's skin as a chewing gum.To remove this hydrocolloid layer, she tried to bring moisture to take off with a washcloth and water.Each time she removed a piece of the gum, the skin was damaged.To avoid being too aggressive, she left the rest of the gum on the skin.This is the first time she has encountered this problem.She feels like the dressing has heated up.¿ however, should further additional information become available, a follow-up report will be submitted.(b)(4).

• Brand Name: DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• MDR Report Key: 7098079
• MDR Text Key: 94193400
• Report Number: 1049092-2017-00066
• 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: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 420061
• Device Lot Number: 6A02949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/09/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 12/13/2017
• Supplement Dates FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention