MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-07-29 for HEGAR 30-530 manufactured by Miltex Instrument Co. Inc..
Report Number | 2431021-1999-00004 |
MDR Report Key | 234961 |
Report Source | 05,06 |
Date Received | 1999-07-29 |
Date of Report | 1999-07-29 |
Date of Event | 1999-07-14 |
Date Mfgr Received | 1999-07-29 |
Date Added to Maude | 1999-08-10 |
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 | 0 |
Event Location | 0 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | HEGAR |
Generic Name | UTERINE DILATOR |
Product Code | HDQ |
Date Received | 1999-07-29 |
Model Number | 30-530 |
Catalog Number | 30-530 |
Lot Number | UNK |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Device Sequence No | 1 |
Device Event Key | 225724 |
Manufacturer | MILTEX INSTRUMENT CO. INC. |
Manufacturer Address | 700 HICKSVILLE RD. BETHPAGE NY 11714 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1999-07-29 |