MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-11-19 for FUTURO? SPORT ADJUSTABLE WRIST SUPPORT N/A 09033EN manufactured by 3m Health Care.
[127611951]
Model, serial, and lot # information was not provided by customer. The device has not been returned by the customer. Product analysis is pending receipt of device from customer. The customer was diagnosed with having a neoprene allergy. The reported symptoms resolved within 3 weeks after prescribed treatment. The product's primary packaging legal disclaimer states: caution:? Some individuals may be sensitive to neoprene or neoprene-blend rubber. If a rash develops, discontinue use and consult a physician.
Patient Sequence No: 1, Text Type: N, H10
[127611952]
A (b)(6) female customer purchased the referenced wrist brace per the recommendation of her staff workers. The wrist support was worn intermittently on (b)(6) 2018, and all day the following day. On (b)(6) 2018, the woman removed the wrist support in the afternoon. The woman alleged the support was removed due to noticing a bad skin reaction. On (b)(6) 2018, the woman reported her wrist was swollen and "looked almost burnt". The woman visited a gp that same day. The doctor diagnosed the woman with having a neoprene allergy. The gp prescribed the woman an unspecified, strong steroid cream and an unspecified antihistamine. The woman was instructed to use the prescribed medications for one week. The woman reported her symptoms resolved within 3 weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2018-00104 |
| MDR Report Key | 8084471 |
| Report Source | CONSUMER |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-19 |
| Date of Event | 2018-09-21 |
| Date Mfgr Received | 2018-09-24 |
| Date Added to Maude | 2018-11-19 |
| 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 | 3M EDUMEX, S.A DE C.V |
| Manufacturer Street | 6620 ORIENTE CALLE RAMON RIVERA LARA |
| Manufacturer City | CD. JUAREZ CHIHUAHUA, MEXICO 32605 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32605 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUTURO? SPORT ADJUSTABLE WRIST SUPPORT |
| Generic Name | LIMB ORTHOSIS |
| Product Code | IQI |
| Date Received | 2018-11-19 |
| Model Number | N/A |
| Catalog Number | 09033EN |
| Lot Number | N/A |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVENUE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-11-19 |