MAUDE Adverse Event Report: H FINE & SONS LTD COMFORT PRO SLING; PATIENT SLING

Model Number NA25508

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Injury (2348)

Event Date 03/14/2014

Event Type  Injury  

Event Description

It was reported to the manufacturer by facility ((b)(6)), per the facility, the clip that holds the sling onto the cradle broke.The resident fell to the floor and hit his head.The resident was transported via 911 to the emergency for evaluation and ct scan.The ct scan was normal.The resident has a bump on the back of his head.Complaint # (b)(4) and ra# (b)(4) was entered into our system for the sling to be returned to joerns (b)(4) for evaluation.As of this writing, the sling has not been returned.

Manufacturer Narrative

Joerns sending the report to the manufacturer.

• Brand Name: COMFORT PRO SLING
• Type of Device: PATIENT SLING
• Manufacturer (Section D): H FINE & SONS LTD; london ; UK
• Manufacturer Contact: felicia banks ; 2100 design rd; arlington, TX 76014 ; 8008260270
• MDR Report Key: 3731348
• MDR Text Key: 20655268
• Report Number: 3009402404-2014-00010
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2014

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: Health Professional
• Device Model Number: NA25508
• Device Catalogue Number: NA25508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2014
• Distributor Facility Aware Date: 03/14/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/24/2014
• Initial Date Manufacturer Received: 02/18/2014
• Initial Date FDA Received: 03/25/2014
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Weight: 98