MAUDE Adverse Event Report: 3M COMPANY FUTURO(TM) WRAP AROUND WRIST SUPPORT ADJ; ORTHOSIS, LIMB BRACE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Erythema (1840); Itching Sensation (1943); Skin Irritation (2076)

Event Date 01/03/2019

Event Type  Injury  

Manufacturer Narrative

There is no established expire date for this product.Initial reporter's occupation was not provided.The device has not been returned to 3m (b)(4) for evaluation.Review of product's 2-year complaint history found no statistical trends.2-year complaint history was reviewed for reported product lot 2017-09-gz and found no other alleged injury complaints against this lot code.Without the product being returned for evaluation, root cause can't be determined at this time.The primary package is labeled with the following caution statement: caution: this product contains natural rubber latex which may cause allergic reactions.Device evaluation pending upon receipt of product.A follow up report will be submitted with new information obtained.

Event Description

A (b)(6) caucasian female customer first wore the referenced wrist support on (b)(6) 2019.On the second day of wear, the woman alleged experiencing an "allergic reaction".The reaction occurred after 12 hours of wear.The woman reported experiencing skin redness, along with itching, under and around the support application site.No known allergies or skin sensitivities were specified.The woman visited a health center and was prescribed loratadine.The symptoms resolved after 7 days.

• Brand Name: FUTURO(TM) WRAP AROUND WRIST SUPPORT ADJ
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): 3M COMPANY; 2510 conway avenue; st. paul,
• Manufacturer (Section G): DEQING CATHAYA HEALTH CARE DEVICES CO., LTD.; no.6,cathaya industrial zone; deqing; huzhou zhejiang, china 31320 0; CH 313200
• Manufacturer Contact: bryan becker ; 2510 conway avenue; st. paul, MN 55144 ; 6517375578
• MDR Report Key: 8266877
• MDR Text Key: 133721907
• Report Number: 2110898-2019-00008
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• 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: 46378IE
• Device Lot Number: 2017-09-GZ
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR