MAUDE Adverse Event Report: ANDOVER HEALTHCARE INC. COFLEX NL; BANDAGE, ELASTIC

Model Number COFLEX NL

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Swelling (2091)

Event Date 06/02/2019

Event Type  Injury  

Event Description

Parent presented (b)(6) pt for lab collection at one of our clinics on (b)(6) 2019.A capillary puncture was performed on a finger.Coflex nl was used to bandage the finger.Parent noted swelling of the finger near the wrap on (b)(6) 2019, and took the pt to a local emergency room.Pt was evaluated and a portion of the finger was determined to be necrotic.The pt was transferred to a hand specialist at children's hosp where it was determined a partial amputation was needed due to restricted blood flow from coflex bandage.We have been unable to find contraindications for coflex bandage use from the mfr or our distributor.

• Brand Name: COFLEX NL
• Type of Device: BANDAGE, ELASTIC
• Manufacturer (Section D): ANDOVER HEALTHCARE INC. ; 9 fanaris drive; salisbury MA 01952
• MDR Report Key: 8731379
• MDR Text Key: 149242813
• Report Number: MW5087595
• 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: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: COFLEX NL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 MO
• Patient Weight: 2