MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-05 for OBSS TRU-SHAPE 6364920 manufactured by Permobil Seating And Positioning.
[137883816]
While the mother alleges that the device contributed to an adverse event, we were not provided any documentation to substantiate that claim. If additional information is received, a final report will be submitted at that time.
Patient Sequence No: 1, Text Type: N, H10
[137883817]
As reported by mother and caregiver: event description: "this form is being filled out by mother/full time caregiver of patient. After 4 long months of waiting for the first fit of the seating system, we had an appointment on (b)(6) 2018. The seat was brought home. Within an hour or so, my daughter started to have breathing difficulty. I noticed when i walked into her room that there was a strong chemical smell. I knew right away it was the seating system. I had to quickly suction out her lungs. After i got the mucus plug out of her lung & got her on her bed & out of her seat, i hooked her up to her ventolin machine. I rushed the seat out of the house and left it out. I contacted the ot at seating on (b)(6) but seating clinic was not open. I dug an old system out of our basement because our daughter's previous seating system was at the hospital. I contacted (b)(4) (permobil) (b)(6)'s rep. He contacted me immediately. Follow up meeting was set up on (b)(6) 2018. He arranged for a (b)(6) meeting with (b)(6) in (b)(6). Ot, pt both could smell the seat when they made an impression in the seat. All agreed that the smell was really bad. It was also agreed with (b)(6) & (b)(6) that there would be a new seat made that would not be sprayed and only covered. I also asked for an additional cover for the seat. Long story short, chemical smell is not so much noticed in large institutional settings. When the systems are in a home, bedroom etc. The smell is there & strong. " detailed consequences: "our daughter suffered a life threatening reaction of her lungs filling up and a large mucus plug that had to be suctioned out of airway. She then had no seating system which she depends on to sit up in her wheelchair. " medical treatment required? "yes, lungs filled up and suctioning was needed. Airway was blocking with mucus plug. She has allergies to chemicals and this is the reaction to air born chemicals. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011208882-2019-00001 |
| MDR Report Key | 8392115 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-05 |
| Date of Report | 2019-03-05 |
| Date of Event | 2018-09-04 |
| Date Added to Maude | 2019-03-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROBIN GERGEN |
| Manufacturer Street | 100 NORTH FLORIDA AVENUE |
| Manufacturer City | BELLEVILLE, |
| Manufacturer G1 | PERMOBIL SEATING AND POSITIONING |
| Manufacturer Street | 1130 SOUTH 3800 WEST |
| Manufacturer City | SALT LAKE CITY UT 84104 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84104 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OBSS TRU-SHAPE |
| Generic Name | OBSS TRU-SHAPE |
| Product Code | IMP |
| Date Received | 2019-03-05 |
| Returned To Mfg | 2018-09-27 |
| Model Number | 6364920 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERMOBIL SEATING AND POSITIONING |
| Manufacturer Address | 1130 SOUTH 3800 WEST SALT LAKE CITY UT 84104 US 84104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2019-03-05 |