MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1998-12-31 for * manufactured by .
| Report Number | 9612030-1998-00011 |
| MDR Report Key | 204720 |
| Report Source | 07 |
| Date Received | 1998-12-31 |
| Date of Event | 1998-12-03 |
| Date Mfgr Received | 1998-12-31 |
| Date Added to Maude | 1999-01-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CYNTHIA PROCENCHER |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618155 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Product Code | LRQ |
| Date Received | 1998-12-31 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 194829 |
| Baseline Brand Name | TRACHEOSTOMY CARE TRAY |
| Baseline Generic Name | TRACH CARE TRAY |
| Baseline Model No | NA |
| Baseline Catalog No | 47800 |
| Baseline ID | NA |
| Baseline Device Family | TRACH CARE KIT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K761190 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-12-31 |