MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2000-01-12 for UNK manufactured by Puritan Bennett Cryogenic Equipment Division.
[161565]
The attorney for the plaintiff reported the following info: (1) while at the hospital, plaintiff was permitted to develop a large burn/ulceration on his thigh/groin area. (2) it is believed that the burn/sore resulted from contact with the oxygen machine. (3) the hospital was negligent in the placement and monitoring of the oxygen machine. (4) the pt has since passed away unrelated to the reported incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825511-2000-00001 |
| MDR Report Key | 258699 |
| Report Source | 00 |
| Date Received | 2000-01-12 |
| Date of Report | 2000-01-12 |
| Date of Event | 1998-01-22 |
| Date Mfgr Received | 1999-12-13 |
| Date Added to Maude | 2000-01-19 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ANGELA DICKSON |
| Manufacturer Street | 5647 DIVIDEND DRIVE |
| Manufacturer City | INDIANAPOLIS IN 46241 |
| Manufacturer Country | US |
| Manufacturer Postal | 46241 |
| Manufacturer Phone | 3172488060 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | UNK |
| Product Code | GXH |
| Date Received | 2000-01-12 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 250528 |
| Manufacturer | PURITAN BENNETT CRYOGENIC EQUIPMENT DIVISION |
| Manufacturer Address | 5647 DIVIDEND DR. INDIANAPOLIS IN 46241 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-01-12 |