OBSS TRU-SHAPE CUSTOM SEAT CUSHIONS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-13 for OBSS TRU-SHAPE CUSTOM SEAT CUSHIONS manufactured by Ottobock Fabrication.

Event Text Entries

[5713753] (b)(6) is a (b)(6) woman with cp, spastic quadriplegia, scoliosis. Wheelchair bound. Requires specialized seat cushion bottom and back for posture and pressure sore issues. Has received two obss cushion sets over time through (b)(6) with first set roughly 10 year ago. Paid for by (b)(6). Both sets emitted an odor similar to the smell of model glue however, the set installed on (b)(6) 2014 were installed within days after receipt by (b)(6) provider and so the fumes have been extreme (little curing time between manufacture and install). Cushions are foam coated with a type of liquid vinyl made by (b)(4). Product id is pdc f-830. On (b)(6) 2014 - cushion set installed at (b)(6). Once in our van, the cushions began emitting strong odor. Realized the warmth of the beater and (b)(6) body warmth were warming up the cushions allowing release of some kind of chemical. Arrived home, (b)(6) coat and clothing smelled of solvent. Put thick bath towel over cushions. Odor leached through towel and clothing consistently every day. Put chair in front of fan each night all night. Better in a. M. But pungent after (b)(6) sits in chair and cushions warm up with her body heat. Can smell just walking past her. Odor leaches through towel, clothing and onto her skin. Kept trying to get the fumes to stop using fan technique and towel barrier. Not working. Getting very worried about toxicity and danger to (b)(6). On (b)(6) 2014 - (on about this date) - too concerned for (b)(6). Remove bottom cushion and place over heat vent to let cushion expel fumes. Back cushion has been screwed into position. Leave in place as i don't know how to properly reinstall. (b)(6) provider is 95 miles away so cannot travel to show them the problem. On (b)(6) 2014 - called (b)(6) left message for (b)(6) explaining odor asking if this is safe and is there anything i can do to speed up getting rid of odor. On (b)(6) 2014 - called (b)(6) again was transferred to a woman in service. Explained type of product and odor. Was told it is non-toxic. Subsequently received call back from (b)(6) who stated also that the odor is non-toxic and does not know what if anything can be done to speed up the process of expelling the fumes. Takes time. Note: we have longterm good relationship with the (b)(6) provider. Trusted this response. Continued using fan at night towels in daytime. No improvement. On (b)(6) 2015- little improvement seems could take months for fumes to end. Called ottobock. Spoke with (b)(6). (b)(6) informed me i need to communicate with ottobock provider rather than directly with manufacturer. Next called (b)(6) provider (b)(6). Spoke with (b)(6), rehab coordinator. Explained situation. Asked she communicate with (b)(6) and ask for msds sheet as well as recommendation for method of dissipating odor/fumes. On (b)(6) 2015 - received email from (b)(6). No method of dissipation, msds sheet attached, (b)(6) says odor wears off over time. On (b)(6) 2015- looking into msds sheet. Starting to understand chemicals listed are dangerous. Appear to be solvents. Call author of the msds sheet, (b)(6) and leave message. On (b)(6) 2015 - called (b)(6). Was forwarded to (b)(6). (b)(6) is the applicator for the plasti dip product onto foam cushions. Explained to (b)(6) the persistent fumes coming from cushions, that my daughter is sitting in these fumes all day. (b)(6) was specific when he stated that the product is cured within two hours after application. I asked what process is used for curing. (b)(6) stated that the cushions are run through a room with fans for two hours and then they are cured. I asked about toxicity with the fumes. (b)(6) stated that the product is fully cured with the two hour fans and is non-toxic. I informed (b)(6) that when in use, the wheelchair bound person's body heat warms the cushions and the fumes emitted are incredibly strong. I asked (b)(6) if there was anything i could do to dissipate the fumes more quickly. (b)(6) subsequently phoned me back after researching the question and stated that there was nothing i could do to get rid of the fumes. On (b)(6) 2015- (on about this date) - received call from (b)(6). Described to (b)(6) my daughter's disability, ottobock product and the fumes. He stated that my description of model glue would be the solvents used in (b)(6). I asked (b)(6) what the proper curing time or process would be that applies to use of this product on foam cushions. (b)(6) stated that curing process would depend upon what material (b)(6) is being applied on. I asked whether the fumes were toxic. (b)(6) responded that without the ability to evaluate the cushions using tools for measurement, he could not say. On (b)(6) 2015 - now i got out my tools and removed the seat back cushion from (b)(6) wheelchair. Both her old cushions were now being used while the new cushions were leaning on vents. On (b)(6) 2015- (on about this date) - i received a call back from (b)(6). He gave me the name of the owner of plasti dip, (b)(6). (b)(6 explained to me after speaking with (b)(6), that plasti dip has had to have several conversations with ottobock over time, about their methods of curing when using (b)(6). On (b)(6) 2015 - as of the date of this complaint, (b)(6) seat cushions are still leaning over vents in our home. The fumes have dissipated quite a bit, but we don't know how to tell if or when they will be safe. I will not re-install them until i am assured they are safe. Additional contact information- ottobock (b)(6) application technician (b)(6.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5042101
MDR Report Key4699464
Date Received2015-04-13
Date of Report2015-03-06
Date of Event2014-11-19
Date Added to Maude2015-04-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameOBSS TRU-SHAPE CUSTOM SEAT CUSHIONS
Generic NameOBSS TRU-SHAPE
Product CodeIMP
Date Received2015-04-13
Device Sequence No1
Device Event Key0
ManufacturerOTTOBOCK FABRICATION
Manufacturer Address3820 GREAK LAKES DR. SALT LAKE CITY UT 84120 US 84120

Device Sequence Number: 2

Brand NameOBSS TRU-SHAPE CUSTOM SEAT CUSHIONS
Generic NameOBSS TRU-SHAPE
Product CodeKNN
Date Received2015-04-13
Device AvailabilityY
Device Sequence No2
Device Event Key0
ManufacturerOTTOBOCK FABRICATION
Manufacturer Address3820 GREAT LAKES DR. SALT LAKE CITY UT 84120 US 84120


Patients

Patient NumberTreatmentOutcomeDate
10 2015-04-13

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