MAUDE Adverse Event Report: 3M HEALTH CARE ACE(TM) HINGED KNEE BRACE; LIMB ORTHOSIS

Model Number N/A

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

Patient Problems Purulent Discharge (1812); Erythema (1840); Swelling (2091)

Event Date 09/21/2017

Event Type  Injury  

Manufacturer Narrative

No information provided.No information provided by customer.Device not returned.Device was not returned by customer; no lot number was provided.Evaluation was not possible.Device manufacture date could not be determined.The product packaging contains the following statement: "caution: some individuals may be sensitive to neoprene or neoprene-blend rubber.If a rash develops, discontinue use and consult a physician.If discomfort or pain results, persists or increases, discontinue use and consult a physician." the patient appeared to follow the instructions for use.Individual patient physiology is the most likely cause of the skin issues.

Event Description

An adult male (age unspecified) wore an ace(tm) hinged knee brace on his left knee for five hours.He alleged a burning sensation under the brace.He went to the emergency room.The man alleged that the area under the brace was red and swollen and was oozing yellow pus from "holes" in his skin.The man was admitted to the hospital for four days where he received intravenous antibiotics, prednisone, and a tetanus shot.The man was discharged with prescriptions for oral cephalexin and prednisone.

• Brand Name: ACE(TM) HINGED KNEE BRACE
• Type of Device: LIMB ORTHOSIS
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway avenue; st. paul MN 55144
• Manufacturer (Section G): WINNING INDUSTRIAL CO., LTD; sha jing keng industrial zone; fushan district; liaobu, dongguan guangdong 52340 1; CH 523401
• Manufacturer Contact: bryan becker ; 2510 conway avenue; st. paul, MN 55144 ; 6517375578
• MDR Report Key: 6974276
• MDR Text Key: 90120622
• Report Number: 2110898-2017-00137
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 209600
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other