MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-06 for DR. COMFORT COZY PINK 10 WIDE 1170-W-10.0 manufactured by Djo, Llc.
[144128491]
Initial reporter occupation: unknown. The customer did not indicate that the device will be returned for evaluation. If the device is returned, a follow-up report will be submitted upon completion of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[144128492]
It was reported that "inserts on the right slipper is coming apart. " the patient reportedly "slipped because the insole came apart and she was hospitalized". She was taken to the emergency room and reportedly "got a big lump on her head when she slipped. " no further information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008579854-2019-00005 |
| MDR Report Key | 8582065 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-06 |
| Date of Report | 2019-05-03 |
| Date of Event | 2018-11-10 |
| Date Mfgr Received | 2019-04-17 |
| Date Added to Maude | 2019-05-06 |
| 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. BRIAN BECKER |
| Manufacturer Street | 2900 LAKE VISTA DRIVE |
| Manufacturer City | LEWISVILLE TX 75067 |
| Manufacturer Country | US |
| Manufacturer Postal | 75067 |
| 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 | DR. COMFORT COZY PINK 10 WIDE |
| Generic Name | ORTHOSIS, CORRECTIVE SHOE |
| Product Code | KNP |
| Date Received | 2019-05-06 |
| Model Number | 1170-W-10.0 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION STREET VISTA CA 920819663 US 920819663 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-05-06 |