MAUDE Adverse Event Report: HOLLISTER DRAINABLE POUCH CLAMP

Model Number 8770

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 06/26/2015

Event Type  malfunction  

Event Description

I am a (b)(6) professional and have lived with an ileostomy since the age of (b)(6) (due to an emergency colectomy).I have used the hollister drainable pouch clamp (8770) since my surgery.Pts are only given one clamp per box of pouches; therefore, the clamp is to last for many weeks.Over the past 2+ years, i have noticed a significant decrease in the product's quality and reliability.The clamp usually only lasts one to two days which leads to leaking from the bag/pouch due to the faulty clamp.This leakage creates soiled undergarments and clothes which is very stressful and inconvenient for an active, professional pt.In addition, the leakage irritates the skin and can cause an infection.I, like many ostomy pts, suffer from a weakened immune system; therefore, i am very susceptible to infections.I have contacted the company on at least three occasions to notify them of my concerns about the clamp's decreased quality and lack of reliability; however, the company's response has been very mediocre.A company rep insinuates it is my imagination or i should try another product.I am fairly certain other ostomy pts who use this product are experiencing the same issues.I would like the company to investigate the mfg of the product.I suspect the mfg location has changed and/or a cheaper ingredient is being used to make the product which has led to its poor quality and unreliability.All lots over the past 2 years.Thank you for investigating hollister and this specific product.Sincerely, (b)(6).

• Brand Name: DRAINABLE POUCH CLAMP
• Type of Device: DRAINABLE POUCH CLAMP
• Manufacturer (Section D): HOLLISTER
• MDR Report Key: 4888375
• MDR Text Key: 17633427
• Report Number: MW5043480
• Device Sequence Number: 1
• Product Code: EXH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8770
• Patient Sequence Number: 1
• Treatment: 440 TO 660 MG OF NAPROXEN SODIUM; LOSARTAN 40 MG Q. D.; 250 TO 500 MCG ADVAIR B. I. D.; 5000 IUS VITAMIN D. Q. D.; 800 MG FOLIC ACID Q. D.; PROVENTIL P. R. R.
• Patient Age: 48 YR
• Patient Weight: 70