MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-01-25 for LAPKO L1300 manufactured by Strive Enterprises.
[19167755]
Right index finger blood blister injury when finger was caught between weight bar and side of machine. Device design issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 30662 |
| MDR Report Key | 30662 |
| Date Received | 1996-01-25 |
| Date of Report | 1996-01-25 |
| Date of Event | 1995-11-01 |
| Date Facility Aware | 1995-11-02 |
| Report Date | 1996-01-25 |
| Date Reported to FDA | 1995-11-02 |
| Date Added to Maude | 1996-03-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAPKO |
| Generic Name | WEIGHT MACHINE |
| Product Code | ISD |
| Date Received | 1996-01-25 |
| Model Number | L1300 |
| Operator | OTHER |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 31722 |
| Manufacturer | STRIVE ENTERPRISES |
| Manufacturer Address | 1375 WASHINGTON RD WASHINGTON PA 15301 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-01-25 |