MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2015-10-27 for DR COMFORT L-5000 manufactured by Dr Comfort, A Djo Llc Company.
[29351000]
Not returned.
Patient Sequence No: 1, Text Type: N, H10
[29351001]
Complaint received that alleges "toes dont fit in the space & the filler gave him an ulcer w. / foot on orthotic the big toe hangs off medially med less filler laterally. There is blood on the orthotic device where excess pressure was applied causing an ulcer to occur". 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 | 3010811527-2015-00002 |
| MDR Report Key | 5180336 |
| Report Source | DISTRIBUTOR |
| Date Received | 2015-10-27 |
| Date of Report | 2015-10-27 |
| Date of Event | 2015-08-31 |
| Date Mfgr Received | 2015-10-13 |
| Date Added to Maude | 2015-10-27 |
| 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 |
| Manufacturer Street | 10300 ENTERPRISE DRIVE |
| 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 |
| Generic Name | TOE FILLER |
| Product Code | KNP |
| Date Received | 2015-10-27 |
| Model Number | L-5000 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 WI 53092 US 53092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-10-27 |