MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC NATURA; PROTECTOR, OSTOMY

Model Number 411804

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

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).

Event Description

Customer reports he noted stool mixed with blood in his pouch the morning of (b)(6) 2019.He was unable to quantify the amount of blood in the pouch.The wafer had been on less than 12 hours.He removed the wafer and applied pressure to the stoma, and the bleeding stopped.The bleeding originated from the outside of the stoma at the 6'0 clock area.He was unable to observe any cut or trauma to the stoma.This issue occurred three times in less than 24 hours.Each time the end user placed a new wafer onto his abdomen.End user states he went to the emergency department three times during the 24 hour period.The first time trip to the emergency department the physician applied pressure to the stoma and the bleeding stopped.He left the emergency room with only gauze on his stoma.When he returned home, he placed a new wafer on his abdomen.A few hours later, the stool mixed with blood was found in his pouch.He was unable to quantify the blood.The second time the end user went to the emergency department the physician stopped the bleeding with pressure and cauterized the stoma.The third trip to the emergency department the physician applied pressure to the stoma and sutured the stoma at the 600 area.No diagnosis or prescription was given by the physician.End user states he cut out the entire mass of his wafer (after suturing), applied talc powder to the wafer adhesive and skin tac to his peristomal skin and held the wafer on with a belt.End user's regular skin care routine is to use an adhesive remover wipe, water to cleanse skin, and allkare barrier wipe with a weartime of 7 days.

Manufacturer Narrative

Correction (g1) - contact office address: (b)(6).Batch record review: lot 9d02573 was manufactured on 04/27/2019, ats #2 manufacturing line.With a total of (b)(4) market units.Complaint investigator id (b)(6) performed a batch record review on 04/05/2021, description natura dura flatmoldlrg 57mm(1x10pk) us, 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 (b)(4) and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.Returned sample evaluation: there is no photograph associated with this case and no unused return sample was 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.The sterilization certificate indicates that the results of the quality tests were satisfactory, and the product received the indicated doses within the precision and accuracy of the dosimetry system employed.In addition, no significant changes have been made in the process or in the product components that could cause the adverse effects reported by the customer.Photos were received for complaint (b)(4) but the condition could not be confirmed through the pictures provided.No pictures were received for the rest of the complaints and per customer description there is no product malfunction confirmed.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: 1049092, manufacturing site: 9618003.

Event Description

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

• Brand Name: NATURA
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• MDR Report Key: 9332104
• MDR Text Key: 166731909
• Report Number: 9618003-2019-05718
• Device Sequence Number: 1
• Product Code: EXE
• 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
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/25/2024
• Device Model Number: 411804
• Device Lot Number: 9D02573
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1