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

Model Number 416417

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

Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Erythema (1840); Itching Sensation (1943); Rash (2033); Blister (4537); Drug Resistant Bacterial Infection (4553)

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 spoke with our company¿s team specialist and reported that she had infection on right thigh where the pouch leaked.Then, afterwards, an additional information was received, and she reported that she developed little red bumps that were itchy on her medial right thigh approximately two to three months after initially starting to use the pouch.The end user verified that she probably also scratched the area due to the itchy rash and clarified that she wore the pouch vertically except for sleeping so that the pouch would not contact this area.She was not certain whether or not the pouch contacted this area during sleep.She had felt some moisture in that area and thought this might be the pouch was leaking.However, she stated that she never actually saw moisture or effluent in the affected area.Approximately five months after developing the rash, she saw her primary physician who prescribed an unknown ointment and warm compresses without providing any specific details.The rash developed a large boil that was the size of the palm of her hand, and she was hospitalized, and intravenous antibiotics were started.Cultures came back positive for a staphylococcus infection and final cultures showed methicillin-resistant staphylococcus aureus (mrsa).Further the boil was drained, and she was hospitalized for approximately a week approximately one year ago.The rash cleared but came back intermittently and took months to clear.At this point, she self-treated with antifungal creams and antibiotic creams.She states it was under control and no photograph was available at this time.She did not recall other details.She has never been told to stop using the product.Even while hospitalized and the rash cleared, she was using this product.

• Brand Name: NATURA+
• Type of Device: POUCH, COLOSTOMY
• 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: 16049264
• MDR Text Key: 306155360
• Report Number: 9618003-2022-05413
• Device Sequence Number: 1
• Product Code: EZQ
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 416417
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2022
• 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: 63
• Patient Sex: Female