MAUDE Adverse Event Report: COLOPLAST A/S COMFEEL PLUS TRANSPARENT HYDROCOLLOID DRESSING; COMFEEL PLUS NEW TRP 10X10

Model Number 3353301720

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

This case is from ae system of nmpa, classified as a serious injury.According to the available information, the patient was admitted to the hospital on (b)(6) 2022 due to diabetic hypertension.The comfeel plus dressing was applied to the patient on (b)(6) 2022.It is reported that the patient complained of rash symptoms accompanied by itching the next day after use of the dressing, resulting in prolonged hospital stay.It was immediately discontinued, and loratadine granules were given 10mg once a day for oral treatment.The patient's symptoms eased within 2 days.No further information is available at this time.

Manufacturer Narrative

Nmpa has downgraded this complaint from serious to non-serious with no rationale.

• Brand Name: COMFEEL PLUS TRANSPARENT HYDROCOLLOID DRESSING
• Type of Device: COMFEEL PLUS NEW TRP 10X10
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST HUNGARY - NYI; coloplast utca 2; nyírbátor 4300 ; HU 4300
• Manufacturer Contact: usmaco maria bosse ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16095471
• MDR Text Key: 306621817
• Report Number: 3006606901-2023-00001
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• PMA/PMN Number: EXCEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3353301720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female