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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: POSEY PRODUCT LIMB HOLDER RESTRAINT, PROTECTIVE

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POSEY PRODUCT LIMB HOLDER RESTRAINT, PROTECTIVE Back to Search Results
Model Number 2551
Device Problem Device Slipped (1584)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Product was discarded and will not be returned. Therefore, this event is reported based on the information provided by the customer and from historical data of similar complaints. A historical review of the complaint database revealed similar complaints for this part number of unintended patient release. Of those returned, broken clips, excessive force, and/or wear and tear has contributed to the malfunction. Without return of the device the reported issue could not be confirmed and without the device lot information the release documentation could not be reviewed. 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. Manufacturer reference file (b)(4). Product not returned.
 
Event Description
Customer contacted us via e-mail. The customer states "(b)(4) we had an issues with mfg # (b)(4)- in the email they said they tossed the malfunctioning restraints - they wanted me to report - do you have any other reported issues of this happening? we had another set of soft limb restraints malfunction last evening that almost resulted in the patient extubating themselves. They are slipping easily when the patient pulls at the restraint. (b)(4) and i advised the nurse to change out the restraints and toss the malfunctioning set due to this being a covid + room. I know we had some issues with this a few months ago and we just wanted to bring it to your attention again. " i have limited other information available. No gtin or lot# was made available. A ts template has been completed and saved to the drive. I am unsure if we will be able to get product back for inspection due to customer comments.
 
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Brand NameLIMB HOLDER
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
POSEY PRODUCT
2530 lindsay privado drive
unit a
ontario CA 91761
Manufacturer Contact
chris rahn
570 enterprise dr
neenah, WI 54956
9207514300
MDR Report Key11532020
MDR Text Key242828482
Report Number2020362-2021-00012
Device Sequence Number1
Product Code FMQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K963413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 02/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2551
Device Catalogue Number2551
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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