MAUDE Adverse Event Report: TG EAKIN LIMITED EAKIN WOUND POUCHES; OSTOMY BAGS

Catalog Number REF 839265

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Erythema (1840); Skin Irritation (2076)

Event Date 11/01/2016

Event Type  malfunction  

Event Description

My wife has a 4" x 5" area of her bowels exposed.A long term care facility misused a wound vacuum pump and destroyed part of the skin graft over her bowels and tore approximately 14 holes in her small bowels.This happened over two years ago.I have been using the eakin wound pouches 9.7 in.X 6.3 in./ 245mm x 160 mm (ref 839265) since their action resulted in her present condition.The pouches that i started out using in 2014 used to be the color of peanut butter and i was able to place the pouch over her bowels and it would last up to 10 or 11 days before it had to be changed because of the material deterioration caused by the acid from her bowels.In (b)(6) of this year, i noticed that the color of the eakin wound pouches that i was getting started to get lighter and lighter in color.The color went from a dark peanut butter color to a light cream color.I contacted, via e-mail, the manufacturer "tg eakin limited" in (b)(4).The response, as to the color change, was that one of the ingredients that goes into making the eakin wound pouches changes color, based on the season of the year and that's what made the color change.I was assured that the color change did not change the make-up of the wound pouch.Based on that info, i should have been receiving some peanut butter pouches by now, but they are still light cream in color.The difference is that when the pouches changed from dark peanut butter in color to a light cream color, they deteriorate faster, to the point that they had to be changed every five days.Tg eakin limited did sent me 10 eakin wound pouches and they were mixed in color from dark peanut butter to the light cream color i get today.Each eakin wound pouch has a "lot number" on the pouch and i think they said that they had two machines that make the pouches.I finally reconciled myself that my wife had to live with the changing of the pouches every five days.Even then, her skin is bright red and very irritated.It is a constant battle to keep her skin from deteriorating any further! in late october of this year, i received a new box of pouches that were marked with lot number 8737.After placing one of these pouches over my wife's open bowel wound, i noticed that the pouch was deteriorating very fast.The pouch was totally destroyed by the acid in just four days.I mean, the only thing left after four days was the clear plastic that the cream material was originally affixed to.I changed the pouch and had to use the same lot number (lot 8737).After just two days, the cream material started deteriorating so fast that i could see her bright red skin through the now clear pouch.I changed this pouch after just three days.I don't know what tg eakin limited did to the make-up of these pouches, but they need to change it back.The trauma of having to go through changing the pouch so often is very bad for my wife and her skin is bright red.If the pouches deteriorate so fast in comparison to the ones that were originally peanut butter in color, my wife's condition will only get worse! i recently contacted (b)(4)., the exclusive us distributor of this product.They said they were aware of the color change in the pouches, i assume, from complaints like mine.The nurse at (b)(4) that i talked to didn't seem too concerned about the change in the deterioration time of the pouches.She said that they would send me a box of 5 pouches and for me to call if i had any other questions or problems! i did receive the box of 5 pouches.Please research the changes to this product and help the thousands of patients like my wife that are now facing a tough challenge.I have some of the dark peanut butter cut outs from back in (b)(6) of this year if those would help your research staff.If the fda knows of another product, that i can use to replace the eakin wound pouches, please contact me at (b)(6).

• Brand Name: EAKIN WOUND POUCHES
• Type of Device: OSTOMY BAGS
• Manufacturer (Section D): TG EAKIN LIMITED
• MDR Report Key: 6135116
• MDR Text Key: 61294909
• Report Number: MW5066384
• 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: 11/28/2016

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: No Information
• Device Catalogue Number: REF 839265
• Device Lot Number: LOT 8373
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/28/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: NA; RX MEDS: METHOADONE FOR FIBROMYALGIA PAIN.
• Patient Age: 64 YR
• Patient Weight: 54