MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-12 for PROSTHETIC LIMB CUSTOM MADE manufactured by .
[20843055]
The problems are throughout the (b)(6) orthotic and prosthetic clinics, and clinics with fabrication and mfg attached to them. Custom made by certified or non certified lab. Non compliance in mfg preparation, delivery, and materials. Abc certified labs, and abc certified clinics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019809 |
| MDR Report Key | 2021759 |
| Date Received | 2011-03-12 |
| Date of Report | 2011-03-12 |
| Date of Event | 1980-01-10 |
| Date Added to Maude | 2011-03-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROSTHETIC LIMB |
| Generic Name | ARTIFICIAL LIMB |
| Product Code | ISS |
| Date Received | 2011-03-12 |
| Returned To Mfg | 1980-01-10 |
| Model Number | CUSTOM MADE |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit | 2011-03-12 |