MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-03-15 for WHEELCHAIR ACCESSORY AIRPTMBDY18 manufactured by Invacare Suzhou.
[17132782]
(b)(4). It was reported by the territory business manager that the airptmbdy18 seat cushion for a power wheelchair was installed over a silver plastic shroud piece with sharp edges accessible to the end user, the technicians, and the caregivers. Additionally, it was reported that upon removing the cushion, inside the silver shroud, there was a metal seat pan, and on the front there was an u shape cutout, which created a second sharp point posing a potential risk for injury. There was no injury reported.
Patient Sequence No: 1, Text Type: D, B5
[17322500]
(b)(4). Only one mdr report will be submitted for this event, although two different complaints were created because of different parts needed to repair the unit, and the file numbers are the following: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004493922-2013-00587 |
| MDR Report Key | 3006959 |
| Report Source | 07 |
| Date Received | 2013-03-15 |
| Date of Report | 2013-02-12 |
| Date Mfgr Received | 2013-02-12 |
| Date Added to Maude | 2013-05-20 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA MEDINA |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE SUZHOU |
| Manufacturer Street | UNIT 28 ZONE,200 SUHONG RD SUZHOU INDUSTRIAL PARK |
| Manufacturer City | JIANGSU, P.R.C. 215021 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 215021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WHEELCHAIR ACCESSORY |
| Generic Name | 890.3910 |
| Product Code | INE |
| Date Received | 2013-03-15 |
| Model Number | AIRPTMBDY18 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE SUZHOU |
| Manufacturer Address | UNIT 28 ZONE,200 SUHONG RD SUZHOU INDUSTRIAL PARK JIANGSU, P.R.C. 215021 CH 215021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-03-15 |