MAUDE Adverse Event Report: CONVATEC SUR-FIT NATURA UROSTOMY POUCH

Model Number CONV-4015-45 SURFIT

Device Problem Fluid/Blood Leak (1250)

Patient Problems Emotional Changes (1831); Sleep Dysfunction (2517)

Event Date 03/28/2014

Event Type  malfunction  

Event Description

My father uses convatec urostomy wafers and pouches.I change his devices weekly because he is (b)(6) and it is difficult for him.On (b)(6) 2014, i changed his devices at 12:30 am.My father decided to change his clothes so i left the room, within 5 minutes.I heard him yell for me, i ran in and saw his jogging paints were wet.After settling him down.I inspected the pouch and it was definitely leaking urine.I removed the device and tested another before applying it to my father.This is the third time in 3 years this has happened.I didn't know to call the company the first time.The second time we had a leak it was the wafer that was defective.I contacted convatec and they sent a new box of wafers.I called today (b)(6) 2014 and they will be sending a box of pouches.They are convatec sur-fit natura urostomy pouches ref 401545, lot number 3k03189.Wafers are convatec sur-fit natura durahesive wafer with collar ref 413162.My father has been using these devices for 11 years and in the past 4-5 years i have had to use tape the wafer sides because the adhesive no longer holds like it did before.We live in a very rural area, anywhere we want to go takes at least an hour, if these devices fail my father would have urine soaked clothes.He has been awake now for 36 hours, he's afraid to go sleep in fear of this device leaking.The first time the wafer leaked all his clothes and bedding were soaked with urine, he is a strong man but that devastated him.These products are very expensive and my father cannot be without them.We need to be able to rely on them.Please let this company know when their products fail it's real people that are horribly affected.Thank you, (b)(6).

• Brand Name: SUR-FIT NATURA UROSTOMY POUCH
• Type of Device: SUR-FIT NATURA UROSTOMY POUCH
• Manufacturer (Section D): CONVATEC
• MDR Report Key: 3724149
• MDR Text Key: 4326331
• Report Number: MW5035422
• Device Sequence Number: 1
• Product Code: EXB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CONV-4015-45 SURFIT
• Device Catalogue Number: 401545
• Device Lot Number: 3X03189
• Other Device ID Number: 6845510361
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/31/2014
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 68