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

Model Number 413419

Device Problems Off-Label Use (1494); Device Handling Problem (3265)

Patient Problems Abrasion (1689); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

Device 3 of 9.The event is considered as misuse.Per the information for use (ifu), a moldable ostomy device should not be cut.A2: age at time of event - 48 years.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.Fda registration number, reporting site: 1049092.Manufacturing site: 9618003.

Event Description

The end user reported that she had a granuloma from six to nine on her stoma which would bleed approximately one to two teaspoons intermittently with the company¿s product.She saw her local ostomy nurse, and she stated that he felt the product and friction, along with hernia which might contribute granuloma formation and resulted in the bleeding.Also stated consumer was not on blood thinners but bleeding resolved independently.Although, she stated that silver nitrate was used once on her stoma by her local ostomy nurse.And she also reported hernia and was waiting for a hernia belt and end user sometimes used to company¿s stoma belt.Consumer used to cut the moldable wafers to enlarge the opening.Her wear time wad two to three days.Also reported that there was no leakage or skin irritation issues under wafer.Corstrata tele-health services had discussed, consent obtained, and referral completed to assist with product recommendation.Samples were not sent.No photo was available at this time.

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 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: 16835913
• MDR Text Key: 314487026
• Report Number: 9618003-2023-00433
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 413419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/29/2023
• 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
• Treatment: COHESIVE SLIM OSTOMY SEALS; DRAINABLE POUCH; STING FREE SKIN BARRIER WIPE; STING-FREE ADHESIVE REMOVER WIPES
• Patient Sex: Female