MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-11-14 for CURETTE UNK manufactured by Unk.
[15188969]
Customer reports that a patient who was discharged after undergoing a hysteroscopy and d & c, returned to the hospital for a surgical removal of a foreign object. The foreign object was identitied as a curette tip, an instrument that would have been used during the proecedure. The curette tip was removed intact and the patient left the o. R. In stable condition. It is not konw what medical devcie company the deivce belongs to therefore all three companies are being notified.
Patient Sequence No: 1, Text Type: D, B5
[15583841]
It has been communicated that the device, product information and lot number is not available for evaluation. Without this information it is not possible for codman to conduct a proper investigation. If at some point the device, product information or lot number does becomes available this complaint will be reopened, investigated and a follow up report will be filed. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2006-00322 |
| MDR Report Key | 781141 |
| Report Source | 05,06 |
| Date Received | 2006-11-14 |
| Date of Event | 2006-10-08 |
| Date Mfgr Received | 2006-10-18 |
| Date Added to Maude | 2006-11-16 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | UNK UNK |
| Manufacturer Street | UNK |
| Manufacturer City | UNK |
| Manufacturer Country | * |
| Manufacturer Phone | 8283106 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURETTE |
| Generic Name | UNK |
| Product Code | HCY |
| Date Received | 2006-11-14 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 768921 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-11-14 |