MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-08 for ENDOSAMPLER manufactured by Medical Gyn Products.
[18191374]
Add'l info rec'd from mfr 3/28/01: mfr would like to inform fda that the complainant did not contact them directly at the time of the complaint, and this is the first time mfr has been informed of this incident. Since the incident report does not include a lot number, it is very difficult to trace the records to the specific lot. Mfr has reviewed the records before and after the incident date and cannot see anything unusual in the mfg of the product. Additionally, mfr has manufactured and sold several thousand endometrial curettes each year since 1995 and has never received complaints of a similar nature.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009452 |
| MDR Report Key | 33970 |
| Date Received | 1996-07-08 |
| Date of Report | 1996-07-03 |
| Date of Event | 1995-01-01 |
| Date Added to Maude | 1996-07-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOSAMPLER |
| Generic Name | ENDOMETRIAL CURETTE |
| Product Code | HHK |
| Date Received | 1996-07-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 35311 |
| Manufacturer | MEDICAL GYN PRODUCTS |
| Manufacturer Address | 328 NO EISENHOWER LN LOMBARD IL 60148 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-07-08 |