MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-12 for NAKED CUSHION SEAT NA:CM02S CM02S manufactured by Invacare Taylor Street.
[141741936]
In an abundance of caution, this event is being reported to the fda, due to the alleged injury and medical treatment required. There was no alleged malfunction/deficiency with the device. The contouru cushions are customized to the individual user, and this cushion was made according to the specifications provided by the dealer. The dealer stated he has modified the cushion by cutting out about one and half inch into the pelvic well area and filled with gel packs to give the end user some comfort and relief. If more information is received this complaint will be revisited.
Patient Sequence No: 1, Text Type: N, H10
[141741937]
The dealer reported that the end user developed a stage 3 pressure wound in mid-(b)(6), after the cm02s seating was received and installed on their wheelchair. The cushion was delivered on (b)(6) 2019. The end user was receiving wound care by having the sore packed and is now having it treated topically at home. The end user parents have removed the cushion from the contour u and started using the old cushion. The dealer reported, that he has cut out about one and a half inch into the pelvic well area, and filled it with gel packs to give the end user some comfort and relief. The end user has a lot of tone and spasm issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2019-00009 |
| MDR Report Key | 8508542 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-12 |
| Date of Report | 2019-03-28 |
| Date Mfgr Received | 2019-04-12 |
| Date Added to Maude | 2019-04-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE TAYLOR STREET |
| Manufacturer Street | 1200 TAYLOR STREET |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44036 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NAKED CUSHION SEAT |
| Generic Name | CUSHION, FLOTATION |
| Product Code | KIC |
| Date Received | 2019-04-12 |
| Model Number | NA:CM02S |
| Catalog Number | CM02S |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 44036 US 44036 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-12 |