MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline; SLING,USHAPED,PAD,HDSUP,450 LB,LRG, EA

Model Number	MDSMPHS3
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2022 while transferring a patient from their bed to their chair the sling straps snapped and the patient fell onto the tile floor.Per the facility, 911 was called and the patient was transferred to the emergency room where they performed imaging on the patient's hips, pelvis, elbow, ribs, and chest.According to the facility the imaging showed a fracture of the '8th rib'.
Additional Manufacturer Narrative
According to the facility on (b)(6) 2022 while transferring a patient from their bed to their chair the sling straps snapped and the patient fell onto the tile floor.Per the facility, 911 was called and the patient was transferred to the emergency room where they performed imaging on the patient's hips, pelvis, elbow, ribs, and chest.According to the facility the imaging showed a fracture of the '8th rib'.The patient was not admitted to the hospital and is reported to be doing 'stable'.The device was purchased in (b)(6) 2021 from medline and has been requested to be returned for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline
• Common Device Name: SLING,USHAPED,PAD,HDSUP,450 LB,LRG, EA
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15272538
• Report Number: 1417592-2022-00145
• Device Sequence Number: 5880303
• Product Code: FSA
• UDI-Device Identifier: 10888277177673
• UDI-Public: 10888277177673
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/22/2022

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
• Operator of Device: Health Professional
• Device Model Number: MDSMPHS3
• Device Catalogue Number: MDSMPHS3
• Device Lot Number: 52SH170001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 147 KG