MAUDE Adverse Event Report: 3M HEALTHCARE 3M COBAN LF LATEX FREE SELF ADHERENT WRAP WITH HAND TEAR; 880.5075 ELASTIC BANDAGE

Catalog Number 2084S

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

Patient Problem Laceration(s) (1946)

Event Date 01/14/2013

Event Type  Injury  

Event Description

Customer reported 2084s coban self adhesive wrap was applied over extremely drape during routine draping for total knee replacement.Alleged on (b)(6) 2013, (b)(6) year old female experienced leg laceration, requiring sutures, post knee replacement when the wrap was being removed with bandage scissors.Customer reported policy change for removal of coban post procedure.Policy changed from: remove by unwrapping or cutting with bandage scissors to remove by unwrapping.

Manufacturer Narrative

Device not provided to manufacturer for evaluation.Complaint type is being monitored and analyzed.

• Brand Name: 3M COBAN LF LATEX FREE SELF ADHERENT WRAP WITH HAND TEAR
• Type of Device: 880.5075 ELASTIC BANDAGE
• Manufacturer (Section D): 3M HEALTHCARE; st. paul MN 55144
• Manufacturer (Section G): 3M HEALTHCARE/3M BROOKINGS; 601 22nd ave south; brookings SD 57006
• Manufacturer Contact: karen rittle,phd,regulatory mgr ; 3m center, bldg. 275-5w-06; st. paul, MN 55144-1000 ; 6517330074
• MDR Report Key: 3807432
• MDR Text Key: 4477981
• Report Number: 2110898-2014-00025
• 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: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2084S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR