MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-16 for ACE? KNEE SUPPORT N/A 207247 manufactured by 3m Health Care.
[145256817]
Product lot # not provided. No lot # was provided, therefore device manufacture date is unknown. Initial reporter's occupation is unknown. The device was not returned for evaluation. Product lot # was not provided. Without a sample, photo, or lot number there is insufficient information to determine root cause. Primary packaging indicates the following: caution: some individuals may be sensitive to neoprene or neoprene-blend rubber. If a rash develops, discontinue use and consult a physician. Complaints were reviewed over the past 24 months for (b)(4) and reported failure. No trends were observed. End of report.
Patient Sequence No: 1, Text Type: N, H10
[145256818]
A (b)(6) female consumer reported she recently underwent left knee meniscus surgery. She wore the referenced knee support overnight on (b)(6) 2019. The knee support was worn for approximately 6 hours. The following morning, the consumer alleged a rash developed on her left leg from the mid-thigh to mid-calf. The rash was described as red dots/spots with some raised areas. The consumer alleged rash spots also appeared on her right leg. The consumer reported the affected areas itched. No known allergies or skin sensitivities were specified. The consumer visited a dermatologist on (b)(6) 2019. The affected area was diagnosed as contact dermatitis. The doctor prescribed clobetasol propionate ointment. Post visit, the consumer reported the affected area appeared to become redder and rash spots started to appear on the back of her arms. The consumer visited the er on (b)(6) 2019 due to rash concerns. She reported the er confirmed the contact dermatitis diagnosis. No additional medication was provided. The consumer visited her primary care md on (b)(6) 2019, to assess the affected area. The consumer reported the rash started to heal and fade by the time follow up appointment was conducted with her dermatologist on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2019-00075 |
| MDR Report Key | 8616000 |
| Report Source | CONSUMER |
| Date Received | 2019-05-16 |
| Date of Report | 2019-05-16 |
| Date of Event | 2019-04-23 |
| Date Mfgr Received | 2019-04-30 |
| Date Added to Maude | 2019-05-16 |
| 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 | ACE? KNEE SUPPORT |
| Generic Name | ORTHOSIS, LIMB BRACE |
| Product Code | IQI |
| Date Received | 2019-05-16 |
| Model Number | N/A |
| Catalog Number | 207247 |
| Lot Number | UNK |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2019-05-16 |