MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. SLINGS, CLIP; IKX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hip Fracture (2349)

Event Date 11/16/2014

Event Type  Injury  

Event Description

Arjohuntleigh received a customer complaint where it was initially reported that the resident was assessed on (b)(6) 2014 as was grimacing with pain and was experiencing difficulty breathing.The facility reported that the resident was receiving care for toileting using an arjohuntleigh hygiene sling.According to the info received, the resident sustained a right fracture of the hip with external rotation.The resident was hospitalized for 2 weeks and had the surgery on the right hip.The resident had never sustained a fall that facility had been aware of.In the info shared by the ministry with the facility it was referenced that the sling which the resident was using was not providing sufficient support and the facility has transitioned the resident over to a full passive sling for all care needs.It was indicated that the exact sling that the resident was using is not available as it has been put into general circulation for other residents.

Manufacturer Narrative

(b)(4).Additional info will be provided following the conclusion of the investigation.(b)(4).

• Brand Name: SLINGS, CLIP
• Type of Device: IKX
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4589765
• MDR Text Key: 5341213
• Report Number: 9681684-2015-00037
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/09/2015,02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2015
• Distributor Facility Aware Date: 02/09/2015
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/09/2015
• Date Manufacturer Received: 02/09/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention