MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-22 for FUTURO? SPORT WRIST SUPPORT N/A 09033EN manufactured by 3m Health Care.
[142621177]
Weight: no information was provided. Lot #: product lot # not provided. Manufacture date: no lot # was provided, therefore device manufacture date is unknown. Health professional: initial reporter's occupation was not provided. The device was not returned for evaluation. Product lot # was not provided. Primary packaging indicates that if discomfort or pain results, persists or increases, discontinue use and consult a physician. Packaging also indicates how to wear. Complaint history was reviewed over the past 24 months for the products global sales code (gsc) of (b)(4) and the reported failure. No trends were observed. A follow up report will be submitted if device is received and analyzed.
Patient Sequence No: 1, Text Type: N, H10
[142621178]
A (b)(6) caucasian female consumer reported she recently underwent surgery for a broken wrist. She purchased and wore the referenced wrist support. Exact duration of wear was unknown. The consumer alleged her arm developed a rash and doubled in size. The reaction was reported to have occurred within approximately 2-3 days of wear. The consumer reported the rash area was very red and raised with bumps. She reported experiencing no pain from the affected area. The consumer reported an allergy to latex. The consumer reported she consulted her husband who is a (b)(6). The consumer's husband advised her to use triamcinolone acetonide ointment 1% on the affected area. The steroid cream was applied for a couple of days to treat symptoms. On (b)(6) 2019, the consumer reported the swelling gradually subsided and went down within a week. A cotton sleeve was worn over the rash area. The skin redness was reported to take longer to resolve and completely diminished within a couple of weeks. The consumer reported her physical therapist recommended she discontinue use of the wrist support and fitted her for a splint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2019-00055 |
| MDR Report Key | 8535375 |
| Report Source | CONSUMER |
| Date Received | 2019-04-22 |
| Date of Report | 2019-05-06 |
| Date of Event | 2019-03-22 |
| Date Mfgr Received | 2019-04-19 |
| Date Added to Maude | 2019-04-22 |
| 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 | 3M EDUMEX, S.A. DE C.V. |
| Manufacturer Street | 6620 ORIENTE CALLE RAMON RIVERA LARA |
| Manufacturer City | CD. JUAREZ CHIHUAHUA, 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 WRIST SUPPORT |
| Generic Name | ORTHOSIS, LIMB BRACE |
| Product Code | IQI |
| Date Received | 2019-04-22 |
| Returned To Mfg | 2019-04-19 |
| Model Number | N/A |
| Catalog Number | 09033EN |
| Lot Number | UNK |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-04-22 |