MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-04-03 for NAKED CUSHION SEAT CM02S/CM02B manufactured by Invacare Taylor Street.
[140882206]
The dealer advised that the patient presented with redness, hives, and irritation. He stated that the reaction was localized to areas of his body in contact with the seat and back cushions, specifically behind the knees to the top of his shoulders. The dealer stated that the patient required medical intervention at a hospital emergency room to control the reaction. He advised that the patient was prescribed medication, but he was not sure of the specifics. He didn't believe respiratory intervention was required. Once removed from the cushion and treated, the patient had no further reaction. In an abundance of caution, this event is being reported to the fda, due to the alleged injury and medical treatment required. However, there was no alleged malfunction/deficiency with the device. The contour cushions are customized to the individual user, and they were made according to the specifications provided by the dealer. An allergic reaction is patient-specific. The dealer advised that the patient has used a vinyl-covered contour system in the past with no issues, so he asked for the cushions to be remade utilizing the same specifications, but with a vinyl covering instead of lycra.
Patient Sequence No: 1, Text Type: N, H10
[140882207]
The dealer reported that the patient experienced a severe skin reaction to the contour seat and back cushions, which were manufactured with a rubber backed lycra cover.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2019-00007 |
| MDR Report Key | 8480160 |
| Report Source | OTHER |
| Date Received | 2019-04-03 |
| Date of Report | 2019-03-07 |
| Date Mfgr Received | 2019-03-07 |
| Date Added to Maude | 2019-04-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE TAYLOR STREET |
| Manufacturer Street | 1200 TAYLOR STREET |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44035 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NAKED CUSHION SEAT |
| Generic Name | CUSHION, WHEELCHAIR |
| Product Code | IMP |
| Date Received | 2019-04-03 |
| Model Number | CM02S/CM02B |
| Catalog Number | CM02S/CM02B |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE TAYLOR STREET |
| Manufacturer Address | 1200 TAYLOR STREET ELYRIA OH 44035 US 44035 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-03 |