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

Model Number 125259

Device Problem Leak/Splash (1354)

Patient Problems Itching Sensation (1943); Rash (2033); Skin Irritation (2076)

Event Date 05/08/2014

Event Type  Injury  

Manufacturer Narrative

Height: 59 inches.Based on the available information, this event is deemed to be a serious injury.No lot number or product evaluation sample is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed and will be monitored through our post market product monitoring review process no additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It is reported that the end-user who has used the same product for many years developed a red; itchy and weeping rash immediately to the right lower quadrant (rlq) of peristomal area and extending about one (1) cm.It is further reported that the end-user was hospitalized about two (2) months related to surgical repair to wrist where the appliance was changed at the hospital by the staff due to leakage resulting in skin irritation and onset of the rash.Lastly, end-user states that she has nystatin powder on hand unrelated to this issue and will apply it to see if there is improvement.The user-was instructed on how to apply the nystatin powder which was prescribed a year ago.A return sample for evaluation is not expected.

• 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
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5284869
• MDR Text Key: 194116941
• Report Number: 9618003-2015-00063
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 125259
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 50 KG