MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2007-12-27 for UNKNOWN manufactured by Unk.
[754940]
Pt had laminaria with string attached inserted in cervix prior to hysterosalpingogram (hsg). When pt arrived for hsg, physician attempted to remove laminaria, with gentle traction on string. String came off, with laminaria remaining in the uterus. The pt required additional procedure in private ob/gyn's office for removal of retained laminaria.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 973010 |
| MDR Report Key | 973010 |
| Report Source | 99 |
| Date Received | 2007-12-27 |
| Date of Report | 2007-12-20 |
| Date of Event | 2007-12-06 |
| Date Facility Aware | 2007-12-06 |
| Report Date | 2007-12-20 |
| Date Added to Maude | 2008-01-09 |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Generic Name | LAMINARIA |
| Product Code | HDY |
| Date Received | 2007-12-27 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Device Expiration Date | 2011-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 943581 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-12-27 |