MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0215 - NATURA+; POUCH, COLOSTOMY

Model Number 416416

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Rash (2033); Urticaria (2278); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.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.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

The end user called to rule out the possible cause of an all over body rash she had been experiencing for the past 3 weeks.She had hives with itching from the tip of her head to the soles of her feet.Reportedly, she had seen a dermatologist twice, and said the health care professional was trying to determine the cause of the hives.She had used the convatec product for 4 years, and her usual wear time was 3-4 days.The only accessory she occasionally used was medline remedy phytoplex powder.The dermatologist gave her a steroid shot, but she got worse and not better.The cause of the skin reaction was unknown and the rash persisted.The end user continued to use the product.No photo is available at this time.

• Brand Name: L3O0215 - NATURA+
• Type of Device: POUCH, COLOSTOMY
• 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: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 10934072
• MDR Text Key: 219131879
• Report Number: 9618003-2020-15382
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 416416
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 91