MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-07-24 for 9684 PF NA manufactured by Nellcor Puritan Bennett.
[18554091]
Report from dealer that end user was getting the mail. The van was leaning toward the drivers side because he was parked in the ditch slightly. When he was backing into his van he was leaning backwards already. He then forced himself over the end barrier and tipped backwards. He went to the hosp for a head injury and burns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183897-1997-00006 |
| MDR Report Key | 108644 |
| Report Source | 07 |
| Date Received | 1997-07-24 |
| Date of Report | 1997-06-24 |
| Date Mfgr Received | 1997-06-24 |
| Device Manufacturer Date | 1997-02-01 |
| Date Added to Maude | 1997-07-30 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 9684 PF |
| Generic Name | AUTOMATIC VAN LIFT |
| Product Code | ING |
| Date Received | 1997-07-24 |
| Model Number | 9684 PF |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 106777 |
| Manufacturer | NELLCOR PURITAN BENNETT |
| Manufacturer Address | 14800 28TH AVE., NORTH PLYMOUTH MN 55447 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1997-07-24 |