MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-10-15 for DILAPAN-S NOT KNOWN * manufactured by Gel Med International.
[520975]
Not known. I have been named in a lawsuit in which a partner used a dilapan and it apparently broke with a piece of it ending in the peritoneal cavity. The claim is that the dilapan caused adhesions, pain, etc. It was inserted prior to a d&c, and it was apparently fragmented and was found at the time of surgery in the abdominal cavity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 69597-2006-00001 |
| MDR Report Key | 772539 |
| Date Received | 2006-10-15 |
| Date of Report | 2006-10-15 |
| Date Facility Aware | 2006-10-09 |
| Report Date | 2006-10-15 |
| Date Reported to FDA | 2006-10-15 |
| Date Reported to Mfgr | 2006-10-15 |
| Date Added to Maude | 2006-10-25 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DILAPAN-S |
| Generic Name | DILAPAN, CERVICAL DILATOR |
| Product Code | MCR |
| Date Received | 2006-10-15 |
| Model Number | NOT KNOWN |
| Catalog Number | * |
| Lot Number | NOT KNOWN |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 760323 |
| Manufacturer | GEL MED INTERNATIONAL |
| Manufacturer Address | * * * EZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-10-15 |