MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-04-15 for BABY CARE KIT BAB7-4673 manufactured by Allegiance - Surgical Group.
| Report Number | 1423537-1997-00063 |
| MDR Report Key | 83706 |
| Report Source | 05 |
| Date Received | 1997-04-15 |
| Date of Event | 1997-03-29 |
| Date Mfgr Received | 1997-04-01 |
| Date Added to Maude | 1997-04-16 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BABY CARE KIT |
| Generic Name | BABY CARE KIT |
| Product Code | FLK |
| Date Received | 1997-04-15 |
| Model Number | BAB7-4673 |
| Catalog Number | BAB7-4673 |
| Lot Number | NA |
| ID Number | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 83012 |
| Manufacturer | ALLEGIANCE - SURGICAL GROUP |
| Manufacturer Address | * * * |
| Baseline Brand Name | BABY CARE KIT |
| Baseline Generic Name | BABY CARE KIT |
| Baseline Model No | BAB7-4673 |
| Baseline Catalog No | BAB7-4673 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-04-15 |