MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-10 for ACE? DELUXE BACK STABILIZER W/ PAD 207399 manufactured by 3m Health Care.
[144673610]
Product lot # was not provided. This product does not have an established shelf life. Initial reporter's occupation is unknown. Product lot # was not provided, therefore device manufacture date is unknown. The device has not been returned for evaluation. Product lot # was not provided. At this time, there are insufficient details to investigate as no photos of the product were included for product confirmation, nor was a product lot number provided. Root cause could not be established. Some consumers may have sensitivities to neoprene. The primary packaging does contain a caution statement for neoprene. Caution: some individuals, may be sensitive to neoprene or neoprene-blend rubber. If a rash develops, discontinue use and consult a physician. Complaint trending was conducted for the past 2 years for product family code, dsb. This appears to be an isolated occurrence. 3m will continue to monitor. End of report.
Patient Sequence No: 1, Text Type: N, H10
[144673611]
A female consumer (age not specified) wore the referenced back stabilizer during work on (b)(6) 2019. The stabilizer was worn for approximately 12 hours. The consumer alleged she broke out in rash. The rash was described as red, itchy splotches on the skin. The consumer reported the rash got progressively worse the next day. No known allergies or skin sensitives were specified. The consumer visited the er and was prescribed famotidine, banophen, and prednisone. Further details regarding reported incident were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2015-00060 |
| MDR Report Key | 8599010 |
| Report Source | CONSUMER |
| Date Received | 2019-05-10 |
| Date of Report | 2019-05-10 |
| Date of Event | 2019-04-12 |
| Date Mfgr Received | 2019-04-15 |
| Date Added to Maude | 2019-05-10 |
| 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 | DONGGUAN NAN YOU SPORTING GOODS ENTERPRISE LTD |
| Manufacturer Street | LINGXIA VILLAGE, LIAOBU TOWN |
| Manufacturer City | DONGGUAN GUANGDONG, CHINA 523409 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 523409 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACE? DELUXE BACK STABILIZER W/ PAD |
| Generic Name | ORTHOSIS, TRUNCAL/ORTHOSIS, LIMB |
| Product Code | MRI |
| Date Received | 2019-05-10 |
| Catalog Number | 207399 |
| Lot Number | UNK |
| 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 AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-05-10 |