MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-12-05 for PRIDE MOBILITY PRODUCTS I2I N/A manufactured by Pride Mobility Products.
[5139962]
Consumer alleges she was driving the device when the flip away went to the other side of where it flips and jammed into her neck close to airway and she beacme red.
Patient Sequence No: 1, Text Type: D, B5
[12617028]
Additional information from the patient's caregiver revealed that the device did not choke the patient and the device was not in use at time of alleged incident.
Patient Sequence No: 1, Text Type: N, H10
[19085437]
Consumer alleges she was driving the device when the flip away went to the other side of where it flips and jammed into her neck close to airway, and she became red.
Patient Sequence No: 1, Text Type: D, B5
[19123624]
The device is not being made available for evaluation at this time. Should the device become available, a follow-up report will then be submitted.
Patient Sequence No: 1, Text Type: N, H10
[27566779]
The component was not fitted properly by the atp which produced chaffing only. Increased size of component in use for a better fit.
Patient Sequence No: 1, Text Type: N, H10
[27566780]
Consumer alleges she was driving the drive when the flip away went to the other side of where it flips and jammed into her neck close to airway and she became red.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530130-2014-00099 |
| MDR Report Key | 4300515 |
| Report Source | 07 |
| Date Received | 2014-12-05 |
| Date of Report | 2015-06-24 |
| Date Mfgr Received | 2015-11-13 |
| Date Added to Maude | 2014-12-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MISS KELLY LIVINGSTON |
| Manufacturer Street | 182 SUSQUEHANNA AVE N/A |
| Manufacturer City | EXETER PA 18643 |
| Manufacturer Country | US |
| Manufacturer Postal | 18643 |
| Manufacturer Phone | 5706555574 |
| Manufacturer G1 | N/A |
| Manufacturer Street | N/A N/A |
| Manufacturer City | N/A |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRIDE MOBILITY PRODUCTS |
| Generic Name | SUPPORT, HEAD AND TRUNK, WHEELCHAIR |
| Product Code | IMS |
| Date Received | 2014-12-05 |
| Model Number | I2I |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRIDE MOBILITY PRODUCTS |
| Manufacturer Address | 182 SUSQUEHANNA AVE N/A EXETER PA 18643 US 18643 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-12-05 |