MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-08 for LAMINARIA * 021003 manufactured by Medgyn Products, Inc..
[4004440]
1) patient diagnosed with a missed spontaneous abortion and had a laminaria placed without complication and a single sponge placed behind. Patient returned the next day to have laminaria removed and under office based dilation and curettage. While trying to remove laminaria, string broke away. Attempt to remove remaining portion of laminaria caused it to fragment into smaller parts. Patient required general anesthesia and operative laparoscopy to remove fragments and have dilation & curettage. Additional information: during laparoscopy discovered patient had congenital anomaly unicornuate uterus with no attachment of the right ovary and fallopian tube to the uterus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3485778 |
| MDR Report Key | 3485778 |
| Date Received | 2013-11-08 |
| Date of Report | 2013-11-08 |
| Date of Event | 2013-10-29 |
| Report Date | 2013-11-08 |
| Date Reported to FDA | 2013-11-08 |
| Date Reported to Mfgr | 2013-11-25 |
| Date Added to Maude | 2013-11-25 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAMINARIA |
| Generic Name | LAMINARIA |
| Product Code | HDY |
| Date Received | 2013-11-08 |
| Model Number | * |
| Catalog Number | 021003 |
| Lot Number | 061611 |
| ID Number | * |
| Device Availability | Y |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDGYN PRODUCTS, INC. |
| Manufacturer Address | 100 W INDUSTRIAL RD ADDISON IL 60101 US 60101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-08 |