MAUDE Adverse Event Report: 3M HEALH CARE 3M¿ SCOTCHCAST¿ COMFORTABLE SPLINT; PROSTHETIC AND ORTHOTIC ACCESSORY

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Cellulitis (1768); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Pt identifier, weight, ethnicity and race: this patient information was not provided.Date of event was not provided.Product lot # and serial # information was not provided.Without the lot number, it is not possible to provide the expiration date, udi, or manufacture date.Device was not returned by customer for evaluation.This is a very rare event based on product complaint history.The initial reporter stated the splint was applied on backwards by the user, in error, due to product unfamiliarity.The instructions for use states :3m¿ scotchcast¿ conformable splint is intended for use in the construction of common orthopedic splints.Specific splinting application suitability should be the responsibility of a qualified, on-site medical professional.Attempts are being made to obtain more information.End of report.

Event Description

A hospital employee reported that the a 3m¿ scotchcast¿ comfortable splint (model 72335) was used on a (b)(6), male infant.Duration of wear or date incident occurred was not specified.The employee reported the splint was applied on backwards by the user, in error, due to product unfamiliarity.The employee reported the infant required hospitalization, reconstructive surgery with skin graft, and treated with antibiotics for cellulitis.Length of hospitalization stay not specified.Patient's current status not specified.

• Brand Name: 3M¿ SCOTCHCAST¿ COMFORTABLE SPLINT
• Type of Device: PROSTHETIC AND ORTHOTIC ACCESSORY
• Manufacturer (Section D): 3M HEALH CARE; 2510 conway ave.; st. paul MN 55144
• Manufacturer (Section G): 3M POLAND MANUFACTURING; wroclaw; ui. kwidzynska 6; wroclaw, poland 51-41 6; PL 51-416
• Manufacturer Contact: dianne gibbs ; 3m center; building 275-5w-06; st. paul, MN 55144-1000 ; 6517379117
• MDR Report Key: 7654310
• MDR Text Key: 112851600
• Report Number: 2110898-2018-00063
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2018

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
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: 72335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 07/02/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 14 MO