MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; SUPPORT, HEAD AND TRUNK, WHEELCHAIR

Model Number I2I

Device Problem Unintended Movement (3026)

Patient Problem Erythema (1840)

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

Manufacturer Narrative

The component was not fitted properly by the atp which produced chaffing only.Increased size of component in use for a better fit.

Event Description

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.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: SUPPORT, HEAD AND TRUNK, WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 182 susquehanna ave; exeter PA 18643
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 182 susquehanna ave; n/a; exeter, PA 18643 ; 5706555574
• MDR Report Key: 4300515
• MDR Text Key: 5139962
• Report Number: 2530130-2014-00099
• Device Sequence Number: 1
• Product Code: IMS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: I2I
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 12/05/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/18/2014; 06/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization