MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-10-24 for ACE(TM) HINGED KNEE BRACE N/A 209600 manufactured by 3m Health Care.
[90120622]
No information provided. No information provided by customer. Device not returned. Device was not returned by customer; no lot number was provided. Evaluation was not possible. Device manufacture date could not be determined. The product packaging contains the following statement: "caution: some individuals may be sensitive to neoprene or neoprene-blend rubber. If a rash develops, discontinue use and consult a physician. If discomfort or pain results, persists or increases, discontinue use and consult a physician. " the patient appeared to follow the instructions for use. Individual patient physiology is the most likely cause of the skin issues.
Patient Sequence No: 1, Text Type: N, H10
[90120623]
An adult male (age unspecified) wore an ace(tm) hinged knee brace on his left knee for five hours. He alleged a burning sensation under the brace. He went to the emergency room. The man alleged that the area under the brace was red and swollen and was oozing yellow pus from "holes" in his skin. The man was admitted to the hospital for four days where he received intravenous antibiotics, prednisone, and a tetanus shot. The man was discharged with prescriptions for oral cephalexin and prednisone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2017-00137 |
| MDR Report Key | 6974276 |
| Report Source | CONSUMER |
| Date Received | 2017-10-24 |
| Date of Report | 2017-10-24 |
| Date of Event | 2017-09-21 |
| Date Mfgr Received | 2017-09-26 |
| Date Added to Maude | 2017-10-24 |
| 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 | WINNING INDUSTRIAL CO., LTD |
| Manufacturer Street | SHA JING KENG INDUSTRIAL ZONE FUSHAN DISTRICT |
| Manufacturer City | LIAOBU, DONGGUAN GUANGDONG 523401 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 523401 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACE(TM) HINGED KNEE BRACE |
| Generic Name | LIMB ORTHOSIS |
| Product Code | IQI |
| Date Received | 2017-10-24 |
| Model Number | N/A |
| Catalog Number | 209600 |
| Lot Number | N/A |
| Device Availability | N |
| 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 | 2017-10-24 |