MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-27 for DILAPAN manufactured by Gynotech, Inc..
[18144300]
Rptr inserted cervical dilator into cervix of pt with cervical stenosis on 2/6/95. When rptr attempted to remove the dilator on 2/7/95, it fractured, leaving several centimeters in the uterus. Pt is an infertility pt. She required general anesthesia and removal with hysteroscopy. Rptr called the co and it turns out the devices fracture. Rptr thinks this product should be recalled and not used unless fixed. This is dangerous to pts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005234 |
| MDR Report Key | 19986 |
| Date Received | 1995-02-27 |
| Date of Report | 1995-02-09 |
| Date of Event | 1995-02-06 |
| Date Added to Maude | 1995-02-28 |
| 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 | DILAPAN |
| Generic Name | CERVICAL DILATOR |
| Product Code | MCR |
| Date Received | 1995-02-27 |
| Device Expiration Date | 1996-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 19881 |
| Manufacturer | GYNOTECH, INC. |
| Manufacturer Address | MIDDLESEX NJ 08846 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1995-02-27 |