MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-01-22 for FUTURO(TM) WRAP AROUND WRIST SUPPORT ADJ N/A 46378IE manufactured by 3m Company.
[133721907]
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.
Patient Sequence No: 1, Text Type: N, H10
[133721908]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2019-00008 |
| MDR Report Key | 8266877 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-01-22 |
| Date of Report | 2019-01-22 |
| Date of Event | 2019-01-03 |
| Date Mfgr Received | 2019-01-03 |
| Device Manufacturer Date | 2017-09-01 |
| Date Added to Maude | 2019-01-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRYAN BECKER |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517375578 |
| Manufacturer G1 | DEQING CATHAYA HEALTH CARE DEVICES CO., LTD. |
| Manufacturer Street | NO.6,CATHAYA INDUSTRIAL ZONE DEQING |
| Manufacturer City | HUZHOU ZHEJIANG, CHINA 313200 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 313200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUTURO(TM) WRAP AROUND WRIST SUPPORT ADJ |
| Generic Name | ORTHOSIS, LIMB BRACE |
| Product Code | IQI |
| Date Received | 2019-01-22 |
| Model Number | N/A |
| Catalog Number | 46378IE |
| Lot Number | 2017-09-GZ |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M COMPANY |
| Manufacturer Address | 2510 CONWAY AVENUE ST. PAUL, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-01-22 |