MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-03-12 for GETINGE 8666 * manufactured by Getinge Disinfection Ab.
[20513428]
Service representative burned with hot water while disconnecting line to feedwater valve from deionized water tank. Rep sustained first degree burns to inner thighs and forearms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616031-2004-00001 |
| MDR Report Key | 534523 |
| Report Source | 07 |
| Date Received | 2004-03-12 |
| Date of Report | 2004-02-12 |
| Date Mfgr Received | 2004-02-12 |
| Device Manufacturer Date | 2003-11-01 |
| Date Added to Maude | 2004-07-16 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KEVIN TOMPKINS |
| Manufacturer Street | 1777 E. HENRIETTA RD |
| Manufacturer City | ROCHESTER NY 14623 |
| Manufacturer Country | US |
| Manufacturer Postal | 14623 |
| Manufacturer Phone | 5854751400 |
| Manufacturer G1 | GETINGE DISINFECTION AB |
| Manufacturer Street | LJUNGADAISGATAN 11 |
| Manufacturer City | VAXJO S-351 15 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | S-351 15 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GETINGE |
| Generic Name | WASHER/DISINFECTOR |
| Product Code | MDZ |
| Date Received | 2004-03-12 |
| Model Number | 8666 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 523788 |
| Manufacturer | GETINGE DISINFECTION AB |
| Manufacturer Address | LJUNGADAISGATAN 11 VAXJO SW S-351 15 |
| Baseline Brand Name | GETINGE |
| Baseline Generic Name | WASHER/DISINFECTOR |
| Baseline Model No | 8666 |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K920413 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-03-12 |