MAUDE Adverse Event Report: SUZHOU MEDSPORT PRODUCTS CO., LTD FISHERBRAND¿ LATEX-FREE COHESIVE FLEXIBLE BANDAGES; ELASTIC BANDAGE

Model Number N/A

Device Problem Use of Device Problem (1670)

Patient Problem Hematoma (1884)

Event Type  Injury  

Event Description

The customer reported a complaint pertaining to the fisher catalog number 22363114, fisherbrand¿ latex-free cohesive flexible bandages.The customer reported that the product was wrapped around the patient's arm after the patient went for a lab draw.At some point after the bandage was wrapped around the patient's arm, the product rolled up and restricted blood flow to the patient's arm.It was communicated the potential exists that the bandage could not be directly seen because it was covered by the patient's gown.The patient developed hemorrhage and had the diagnosis of compartment syndrome in the right forearm intramuscular hematoma.The customer reported that the patient was taking a blood thinning medication, and the patient had to go to surgery for a fasciotomy, followed by another surgery for a secondary closure.The customer stated that the standard of care for patients on anticoagulant is to apply pressure and not to wrap a patient's arm with a bandage.In this case, the customer did not follow the established standard of care for this patient.

• Brand Name: FISHERBRAND¿ LATEX-FREE COHESIVE FLEXIBLE BANDAGES
• Type of Device: ELASTIC BANDAGE
• Manufacturer (Section D): SUZHOU MEDSPORT PRODUCTS CO., LTD; no. 128 fangzhou road; suzhou industrial park, suzhou, china 21512 3; CH 215123
• MDR Report Key: 6541716
• MDR Text Key: 74357788
• Report Number: 2517925-2017-00001
• Device Sequence Number: 1
• Product Code: FQM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: 22363114
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/03/2017
• Distributor Facility Aware Date: 04/04/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR