MAUDE Adverse Event Report: 3M HEALTH CARE ACE¿ BRAND NEOPRENE ANKLE SUPPORT; ORTHOSIS, LIMB BRACE

Model Number N/A

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

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 11/30/2016

Event Type  Injury  

Manufacturer Narrative

Weight: no information provided.Expiration date and lot number not applicable.Device manufacture date is identified by an alpha code located on the brace label.The returned product was evaluated.Product seams and material were intact.The consumer did not specify if she continued to wear the support between the alleged onset of symptoms on (b)(6) and seeking medical care on (b)(6).The product packaging contains the statements "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." customer misuse is possible.End of report.

Event Description

A female customer started wearing the referenced ankle support in approximately mid (b)(6) 2016.The woman denied any issue with the brace.On about (b)(6) 2016 the woman alleged itch and a rash on her right foot where the brace touched her skin.The woman applied topical prescription mometasone furoate that she had for another issue.On december 4, the woman went to an urgent care clinic.The physician diagnosed the skin issue as an 'allergic reaction, contact dermatitis'.The physician recommended over-the-counter topical sarnatm (pramocaine) and continued use of mometasone.By december 13 the area was improving.Additional information received 27dec2016 - the customer alleged the itching on her foot became "unbearable".She used topical and oral benadryl (diphenhydramine) without success.The woman went to an urgent care facility on (b)(6) 2016 where she was given a six day course of oral methylprednisolone.

• Brand Name: ACE¿ BRAND NEOPRENE ANKLE SUPPORT
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): WINNING INDUSTRIAL CO., LTD.; sha jing keng industrial zone; fushan district, liabou; dongguan guangdong, ; CH
• Manufacturer Contact: bryan becker ; 2510 conway avenue; st. paul, MN 55144 ; 6517375578
• MDR Report Key: 6266730
• MDR Text Key: 65410461
• Report Number: 2110898-2017-00006
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• 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: 207248
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR