MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0200 - NATURA; POUCH, COLOSTOMY

Model Number 401527

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

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033)

Event Type  Injury  

Manufacturer Narrative

Contact office address: (b)(6).Based on the available information, this event is deemed to be a serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: (b)(4), manufacturing site: (b)(4).

Event Description

The end user reported that she had used this product with no issues until this box and she noted that she developed itching under the pouch material that had progressed into a red rash and now was over her entire body.She believed it was more of an allergy.However, the end user reported no known allergies.She also reported that she went to her doctor who did not order any medication and advised her to find another product.The end user was offered various samples as an alternative, but consumer did not want to trial any other product.She mentioned that she did not experience leakage.She reported that when she applied a piece of material in between her pouch and her skin, the rash and itchy began to subside.The end user continued to use soft cotton material to separate pouch from touching skin since that worked well.She was also using over the counter zinc oxide 25% protectant spray to affected area and noted improvement.Reportedly, the patient continued using the product.No photo is available at this time.

Event Description

To date no additional patient or event details have been received.

Manufacturer Narrative

Additional information - this emdr is being submitted to include the below: h6 - investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions h10: investigation summary correction (g1) - contact office address: (b)(4).Batch record review: lot 1a02143 was manufactured on 15/jan/2021, in the 12e manufacturing line with a total of (b)(4) mkus.Complaint investigator id (b)(4) performed a batch record review on 18/nov/2021, to verify if all the applicable procedures were followed and no issues were found, all the components for assembly were correct per bom and all the tooling information documented was also correct, sap material id 1003662 and manufacturing order (b)(4).No discrepancies related to the issue reported were found.Returned sample evaluation: no photos were received and no unused return samples were expected.Conclusion summary of the related event: based on the preliminary investigation performed, no issues related to the customer experience were found in the batch record review.No significant changes were made in the process or in the product components that could cause the adverse effects reported by the customer.The product was used in their shelf life.No photos or samples were received and per customer description there was not enough information about how the product was used that led us to a conclusion, therefore, there was no product malfunction confirmed.The investigation associated with related event was approved and complete.No additional action is required, and this complaint 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.Fda registration number.Reporting site: 1049092.Manufacturing site: 9618003.

• Brand Name: L3O0200 - 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: 12473849
• MDR Text Key: 271453154
• Report Number: 9618003-2021-02035
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 401527
• Device Lot Number: 1A02143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/15/2021
• 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 Sex: Female