MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-01 for GUARDIAN 90-214 90-214 (TALL ADULT) manufactured by Guardian Products, Inc..
[90626]
Locking pin disengaged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020334-1997-00046 |
| MDR Report Key | 110030 |
| Date Received | 1997-08-01 |
| Date of Report | 1997-07-24 |
| Date of Event | 1997-04-24 |
| Date Mfgr Received | 1997-04-24 |
| Date Added to Maude | 1997-08-04 |
| 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 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GUARDIAN |
| Generic Name | RED DOT CRUTCH |
| Product Code | IMZ |
| Date Received | 1997-08-01 |
| Returned To Mfg | 1997-06-16 |
| Model Number | 90-214 |
| Catalog Number | 90-214 (TALL ADULT) |
| Lot Number | NA |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 108100 |
| Manufacturer | GUARDIAN PRODUCTS, INC. |
| Manufacturer Address | 4175 GUARDIAN ST. SIMI VALLEY CA 93063 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-08-01 |