MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-10-03 for WHEELCHAIR ACCESSORY IHCSBAAS manufactured by Invamex.
[20796511]
The facility states the resident swung their legs out of bed and allegedly caught the back of their leg on the weld of an assist bar, resulting in a cut that required 16 stitches.
Patient Sequence No: 1, Text Type: D, B5
[20909986]
(b)(4) has been issued for the return of this device. The age of model ihcsbaas with serial number (b)(4) is unknown. The consumer swung their legs onto the weldment causing their leg to cut and eventually need stitches. The height of the weldment is unknown. It is unknown if the weldment experienced distortion. The medical condition, stability and medication regimen of the consumer is unknown. It is unknown if the consumer was provided instructions for entering and exiting the bed. It is unknown if obstacles were in place causing the consumers legs to swing in the direction of the lift bar weldment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616091-2011-00012 |
| MDR Report Key | 2271549 |
| Report Source | 06 |
| Date Received | 2011-10-03 |
| Date of Report | 2011-09-30 |
| Date of Event | 2011-09-07 |
| Date Mfgr Received | 2011-09-08 |
| Date Added to Maude | 2012-06-29 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JEFF BOND |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVAMEX |
| Manufacturer Street | P O DRAWER BB |
| Manufacturer City | HIDALGO TX 78557 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78557 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WHEELCHAIR ACCESSORY |
| Generic Name | 890.3910 |
| Product Code | KNO |
| Date Received | 2011-10-03 |
| Model Number | IHCSBAAS |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVAMEX |
| Manufacturer Address | P O DRAWER BB HIDALGO TX 78557 US 78557 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-10-03 |