MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-10-08 for ACE? COMPRESSION CALF SLEEVE? N/A 901510 manufactured by 3m Health Care.
| Report Number | 2110898-2019-00112 |
| MDR Report Key | 9167000 |
| Report Source | CONSUMER |
| Date Received | 2019-10-08 |
| Date of Report | 2019-10-08 |
| Date of Event | 2019-09-03 |
| Date Mfgr Received | 2019-09-10 |
| Device Manufacturer Date | 2018-05-08 |
| Date Added to Maude | 2019-10-08 |
| 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 |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACE? COMPRESSION CALF SLEEVE? |
| Generic Name | ORTHOSIS, LIMB BRACE |
| Product Code | IQI |
| Date Received | 2019-10-08 |
| Model Number | N/A |
| Catalog Number | 901510 |
| Lot Number | 8192 |
| 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. Required No Informationntervention | 2019-10-08 |