MAUDE Adverse Event Report: 3M HEALTH CARE 3M SCOTCHCAST ONE STEP SPLINT; PROSTHETIC AND ORTHOTIC ACCESSORY

Catalog Number 86335

Device Problem Insufficient Information (3190)

Patient Problems Irritation (1941); Skin Irritation (2076); Skin Inflammation (2443)

Event Date 01/23/2015

Event Type  Injury  

Event Description

A male had a 3m splint placed on his left forearm and elbow on (b)(6) 2015 following an accident the day before.The splint and his arm were wrapped in an elastic bandage.Within the next few days the male alleged blistering and weeping of the skin around the edge of the splint.The splint was removed around (b)(6) 2015.The male alleged 2-3cm blisters over his arm; the blisters were allegedly worse on the inner side of the arm and on the elbow joint.The male was given an unidentified steroid injection, fluocinonide cream, furosemide (a diuretic) and an unidentified antibiotic.His surgery was postponed for one week.Additional information provided by the male that occurred subsequent to the reportable event noted above.The male had surgery on his left elbow on approximately (b)(6) 2015 that involved a joint implant (radial head).The male alleged his wound did not heal adequately.Bactrim was prescribed which he stated had no effect.The implant was removed and a picc line placed on (b)(6) 2015 for receiving iv vancomycin.

Manufacturer Narrative

This is a very rare event based on product complaint history.

• Brand Name: 3M SCOTCHCAST ONE STEP SPLINT
• Type of Device: PROSTHETIC AND ORTHOTIC ACCESSORY
• Manufacturer (Section D): 3M HEALTH CARE; st. paul MN 55144
• Manufacturer Contact: linda johnsen ; 3m center, bldg. 275-5w-06; st. paul, MN 55144-1000 ; 6517374376
• MDR Report Key: 4595222
• MDR Text Key: 5464492
• Report Number: 2110898-2015-00011
• Device Sequence Number: 1
• Product Code: IPM
• 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: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2017
• Device Catalogue Number: 86335
• Device Lot Number: 2017-07 UG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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
• Treatment: PICC LINE IV VANCOMYCIN; JOINT IMPLANT
• Patient Outcome(s): Other
• Patient Age: 64 YR