MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-12-30 for RESPIRATORY KIT RES90RESUB manufactured by .
| Report Number | 1423507-1999-00374 |
| MDR Report Key | 257306 |
| Report Source | 05,06 |
| Date Received | 1999-12-30 |
| Date of Report | 1999-12-30 |
| Date of Event | 1999-10-18 |
| Date Mfgr Received | 1999-11-30 |
| Device Manufacturer Date | 1999-04-01 |
| Date Added to Maude | 2000-01-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA SHARPE-GREGG |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475783636 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESPIRATORY KIT |
| Generic Name | RESPIRATORY KIT |
| Product Code | MOD |
| Date Received | 1999-12-30 |
| Model Number | RES90RESUB |
| Catalog Number | RES90RESUB |
| Lot Number | UNK |
| ID Number | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 241677 |
| Baseline Device Family | RESPIRATORY KIT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-12-30 |