MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-01-10 for ANNIE BLUE 9 XWIDE 4550-X-09.0 manufactured by Dr. Comfort, A Djo, Llc Company.
[132773122]
The customer reported that the patient's "feet had swollen up after wearing shoes for nine days". The customer purchased a pair of shoes for his mother's bad feet on the advice of a local foot specialist. After less than a week in the shoes, the patient's son was called to the rest home where the patient lives and learned that the patient's feet, from the bridge to the toes, allegedly had a reaction to the fabric of the shoes. The patient spent many hours in accident and emergency (a&e), which reportedly confirmed that the shoe lining caused the reaction. The patient is reportedly "in danger of infection and other problems".
Patient Sequence No: 1, Text Type: D, B5
[134201301]
The device is not available for evaluation. If the device becomes available as such, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008579854-2019-00003 |
| MDR Report Key | 8236369 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-01-10 |
| Date of Report | 2019-01-10 |
| Date of Event | 2018-12-13 |
| Date Mfgr Received | 2018-12-26 |
| Date Added to Maude | 2019-01-10 |
| 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 | BRIAN BECKER |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer Phone | 7607343126 |
| Manufacturer G1 | DR. COMFORT, A DJO, LLC COMPANY |
| Manufacturer Street | 10300 ENTERPRISE DR. |
| Manufacturer City | MEQUON WI 53092 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53092 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANNIE BLUE 9 XWIDE |
| Generic Name | ORTHOSIS, CORRECTIVE SHOE |
| Product Code | KNP |
| Date Received | 2019-01-10 |
| Model Number | 4550-X-09.0 |
| Lot Number | 8382398 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DR. COMFORT, A DJO, LLC COMPANY |
| Manufacturer Address | 10300 ENTERPRISE DR. MEQUON WI 53092 US 53092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-01-10 |