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

Model Number 187955

Device Problems Device Expiration Issue (1216); Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problems Bacterial Infection (1735); Inflammation (1932); Skin Irritation (2076); Tissue Damage (2104); Burning Sensation (2146); Ulcer (2274)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).Based on the available information, this event is deemed to be a serious injury.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.  additional information has been requested, however 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 has been using the duoderm extra thin dressing for three (3) years as directed by her doctor to treat venous leg ulcers.End user reports that on (b)(6) 2018 she purchased duoderm et in the pharmacy within the neighborhood, however when she bought it, she did not verify expiration date.The dressing was given to end user's treating doctor for review and cure routine.Once the doctor placed the dressing on the wound, the end user reports burning and redness in the leg.The doctor verified the expiration date of dressing and it was dec-2017.It was stated that the doctor instructed the end user not to remove the dressing from the wound until the next day, despite knowing that it was obsolete.The next day when the dressing was removed, the ulcer showed a slight infection.End user states the ulcer is very large, her leg is totally swollen and she cannot walk.Her doctor removed the duoderm of her treatment and is using vaseline gel gauze and jelonet gauze.

• Brand Name: DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• MDR Report Key: 7473580
• MDR Text Key: 106918818
• Report Number: 9618003-2018-00145
• 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,foreign
• Reporter Occupation: Other
• Type of Report: Initial

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: Lay User/Patient
• Device Model Number: 187955
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention