MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-04-02 for 1219930ERINE CURETTE SIZE #3 GL 1600-003 manufactured by Allegiance-surgical Grp.
[54140]
Account reported that during a d & c procedure the tip of the curette fractured off into the pt's uterus. The physician used an intrauterine grasping forceps to remove the curette tip from the pt's uterus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-1997-00059 |
| MDR Report Key | 81080 |
| Report Source | 05,06 |
| Date Received | 1997-04-02 |
| Date of Report | 1997-04-02 |
| Report Date | 1997-04-02 |
| Date Reported to FDA | 1997-04-02 |
| Date Reported to Mfgr | 1997-03-28 |
| Date Mfgr Received | 1997-03-28 |
| Device Manufacturer Date | 1972-01-01 |
| Date Added to Maude | 1997-04-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1219930ERINE CURETTE SIZE #3 |
| Generic Name | 1996INE CURETTE |
| Product Code | HCY |
| Date Received | 1997-04-02 |
| Returned To Mfg | 1997-03-31 |
| Model Number | GL 1600-003 |
| Catalog Number | GL 1600-003 |
| Lot Number | P |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 25 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 80520 |
| Manufacturer | ALLEGIANCE-SURGICAL GRP |
| Manufacturer Address | 1500 WAUKEGAN RD-BLDG. K MCGAW PARK IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-04-02 |