MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC NATURA; BAG, URINARY, ILEOSTOMY

Model Number 401544

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

Patient Problems Cellulitis (1768); Rash (2033)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event seemed 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 patient's wife reported that her husband developed a rash on his skin where the pouch touched the skin.The patient's wife could not describe the rash but stated that according to her, it was yeast and began to treat the skin with an over the counter (otc) desinex powder.The patient¿s wife stated they live in florida and her husband loves to be outside all day due to which he perspires, which might have caused the rash.She stated the rash turned into cellulitis three weeks prior which needed to be treated with a prescribed oral antibiotic after seeing a medical doctor.The patient completed the antibiotic course (drug name unknown) and the skin became normal.The reporter feels the pouch material caused the rash.The end user stopped using the product and used an alternate brand.

• Brand Name: NATURA
• Type of Device: BAG, URINARY, ILEOSTOMY
• 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: 9021267
• MDR Text Key: 161197274
• Report Number: 9618003-2019-05276
• Device Sequence Number: 1
• Product Code: EXH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 401544
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2019
• 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: N
• Patient Sequence Number: 1