MAUDE Adverse Event Report: POSEY COMPANY FOAM LIMB HOLDER; RESTRAINT, PROTECTIVE

Model Number 2532

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device not available.

Event Description

The customer reported that there is a slippage issue when the restraint is filled with fluid.The patient is able to maneuver there way out.The date the issue was discovered is unknown and no patient injuries were reported.

Manufacturer Narrative

Evaluation results: it has been confirmed that the product will not be returned as it has been discarded.Without the return of the product for evaluation, and without clarification of the reported issue the root cause cannot be determined.Historical data was reviewed; however, it did not reveal any similar instances of moisture causing "slippage" issues for this particular device.The instructions for use warn the user that, "this device is designed for use in normal indoor environments.This device may be stored in ambient warehouse temperatures at normal humidity levels.Avoid excess moisture or high humidity that may damage product materials." at this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.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 mode will be assessed, documented and acted upon as warranted.(b)(4).

Event Description

Supplemental medwatch required for additional information.

• Brand Name: FOAM LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY COMPANY; 5635 peck rd.; arcadia CA 91006
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 6553121
• MDR Text Key: 74896284
• Report Number: 2020362-2017-00013
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 2532
• Device Catalogue Number: 2532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2017
• Initial Date FDA Received: 05/08/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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