MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2001-10-09 for FIXED STRUT ADAPTER 15048M manufactured by Usmc.
[217096]
The patient was an above the knee amputee who was on usmc strut adapter. The adapter broke and the patient fell down and was injured. The pt's hip was fractured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2013693-2001-00002 |
| MDR Report Key | 355390 |
| Report Source | 08 |
| Date Received | 2001-10-09 |
| Date Mfgr Received | 2001-09-14 |
| Device Manufacturer Date | 1999-01-01 |
| Date Added to Maude | 2001-10-15 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | SERRAH NAMINI |
| Manufacturer Street | 180 N. SAN GABRIEL BLVD. |
| Manufacturer City | PASADENA CA 91107 |
| Manufacturer Country | US |
| Manufacturer Postal | 91107 |
| Manufacturer Phone | 6267960477 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIXED STRUT ADAPTER |
| Generic Name | PROSTHETIC |
| Product Code | IQO |
| Date Received | 2001-10-09 |
| Model Number | 15048M |
| Catalog Number | 15048M |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 344611 |
| Manufacturer | USMC |
| Manufacturer Address | 180 N. SAN GABRIEL BLVD. PASADENA CA 91107 US |
| Baseline Brand Name | STRUT ADAPTER |
| Baseline Generic Name | STRUT ADAPTER |
| Baseline Model No | 15048M |
| Baseline Catalog No | 15048 |
| Baseline ID | 15048 |
| Baseline Device Family | STRUT ADAPTER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2001-10-09 |