MAUDE Adverse Event Report: POSEY PRODUCTS LLC LATERAL ARM SUPPORT; ACCESSORIES, WHEELCHAIR

Model Number 6320

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Skin Tears (2516)

Event Type  Injury  

Manufacturer Narrative

Product is scheduled to be returned but have not been received in by manufacturing at the time of this report.Therefore, this report is based solely on the information provided by the customer.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instruction for use were reviewed and determined to provide adequate instructions and warning for safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.All complaints are intended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.(b)(4).

Event Description

Customer reported while the lateral armrest was in use with a patient the patient suffered a skin tear from the "posey tag" that is sewn on the armrest.Customer provided additional information stating the skin tear was treated by band-aid from a nurse.Customer stated the label that scratched the patient was a raised hard rubber material.The date the incident occurred was not reported.

Manufacturer Narrative

After multiple attempts, the product was not received in.Without the device, the reported issue could not be confirmed and possible causes for patient injury could not be determined.Historical data review showed no other complaint against this or similar products where the customer suffered skin tears from the tags.The instruction for use was reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.The ifu stated "inspect before each use: check for broken stitches; or torn, cut or frayed material.Do not use soiled or damaged products." at this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure code will be assessed, documented and acted upon as warranted.(b)(4).

Event Description

Supplemental required for additional information.

• Brand Name: LATERAL ARM SUPPORT
• Type of Device: ACCESSORIES, WHEELCHAIR
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck road; arcadia 91006
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 7289534
• MDR Text Key: 100704714
• Report Number: 2020362-2018-00016
• Device Sequence Number: 1
• Product Code: KNO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2018

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: Nurse
• Device Model Number: 6320
• Device Catalogue Number: 6320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 02/22/2018
• Supplement Dates Manufacturer Received: 02/02/2018
• Supplement Dates FDA Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention