MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-01-28 for DR COMFORT L-5000 manufactured by Dr Comfort, A Djo Llc Company.
[37027880]
Not returned.
Patient Sequence No: 1, Text Type: N, H10
[37027881]
Complaint received that alleges "developed blister bilaterally (ulcer) & was in the hospital for 3 days with wounds". Questionnaire was not received from clinician and/or patient. Device not returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008579854-2016-00001 |
| MDR Report Key | 5396726 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-01-28 |
| Date of Report | 2016-01-28 |
| Date of Event | 2015-11-16 |
| Date Mfgr Received | 2016-01-19 |
| Date Added to Maude | 2016-01-28 |
| 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 | WILLIAM FISHER |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607313126 |
| Manufacturer G1 | DR COMFORT, A DJO, LLC COMPANY |
| Manufacturer Street | 10300 ENTERPRISE DRIVE |
| Manufacturer City | MEQUON 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 |
| Generic Name | TOE FILLER |
| Product Code | KNP |
| Date Received | 2016-01-28 |
| Returned To Mfg | 2016-01-19 |
| Model Number | L-5000 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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 DRIVE MEQUON 53092 US 53092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-01-28 |