MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC

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

Patient Problems Erythema (1840); Itching Sensation (1943); Fungal Infection (2419); Tissue Breakdown (2681); Skin Infection (4544); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Product name: actual ostomy product is unknown.The end user could only provide: ref number.510(k) number: exempt, product code: exe, common device name: protector, ostomy.Contact office address: (b)(4).Based on the available information, this event is deemed to be a reportable malfunction.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 reported that he had to discontinue the use of durahesive wafer with tape collar due to redness, itching and weeping under the tape collar portion of the wafer.He stated that it was occurred approximately fifteen years ago and he could not provide the reference or lot number information.He just remembered that it was the convatec durahesive with tape collar.He remembered at the time he saw a physician and was diagnosed with yeast infection and given an oral medication which did not help.He did not recall the name.He stated he was later provided with olux foam that cleared it up and he discontinued using the product with tape once he realized what was causing it.No photo is available at this time.

• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 13091659
• MDR Text Key: 282806264
• Report Number: 9618003-2021-02881
• Device Sequence Number: 1
• Product Code: EXE
• 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: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 71
• Patient Sex: Male