MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-09-11 for BUSSE LAMINARIA 3 MM SIZE 206 manufactured by Busse Hospital Disposables.
| Report Number | 2433012-1997-00004 |
| MDR Report Key | 118852 |
| Report Source | 05,06 |
| Date Received | 1997-09-11 |
| Date of Report | 1997-09-11 |
| Date of Event | 1997-06-21 |
| Report Date | 1997-09-11 |
| Date Reported to Mfgr | 1997-09-10 |
| Device Manufacturer Date | 1997-01-01 |
| Date Added to Maude | 1997-09-12 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUSSE LAMINARIA |
| Generic Name | SINGLE USE 3 MM CERVICAL DILATOR, DISPOSABLE |
| Product Code | HDY |
| Date Received | 1997-09-11 |
| Model Number | 3 MM SIZE |
| Catalog Number | 206 |
| Lot Number | 96894 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | M |
| Device Sequence No | 1 |
| Device Event Key | 116524 |
| Manufacturer | BUSSE HOSPITAL DISPOSABLES |
| Manufacturer Address | 75 ARKAY DRIVE HAUPPAUGE NY 11788 US |
| Baseline Brand Name | BUSSE LAMINARIA |
| Baseline Generic Name | SINGLE USE 3 MM CERVICAL DILATOR, DISPOSABLE |
| Baseline Model No | 3 MM SIZE |
| Baseline Catalog No | 206 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-09-11 |