MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-10 for DILATERIA (LAMINARIA JAPONICA) 210 (3 MM) manufactured by Milex Products, Inc..
[12415]
6/28/94 pt. Had a laparoscopy for pelvic pain ovarian cyst and status post endometriosis. At the time of surgery, pt. Presented with very tight cervical stenosis. At the completion of the operative procedure, 3, 3mm laminaria were applied and packed in situ. 6/29/94 attempted to remove laminaria and were unsuccessful. Pt. Given a light anesthesia and still unable to remove. All three broke at the plastic hub when attempting to remove. Pt. Taken to the operative suite, given a general anesthesia, had a d&d with an operative hysteroscopy for removal of the laminaria. Procedure lasted 1 1/2 hours. Patient discharged at 2120, 12 hours later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 25469 |
| MDR Report Key | 25469 |
| Date Received | 1995-01-10 |
| Date of Report | 1994-07-05 |
| Date of Event | 1994-06-29 |
| Date Facility Aware | 1994-06-29 |
| Report Date | 1994-07-05 |
| Date Reported to Mfgr | 1994-07-05 |
| Date Added to Maude | 1995-09-14 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | DILATERIA (LAMINARIA JAPONICA) |
| Generic Name | CERVICAL DILATOR |
| Product Code | HDY |
| Date Received | 1995-01-10 |
| Model Number | 210 (3 MM) |
| Lot Number | 931510 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 25967 |
| Manufacturer | MILEX PRODUCTS, INC. |
| Manufacturer Address | 5915 NORTHWEST HIGHWAY CHICAGO IL 60631 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1995-01-10 |