MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-19 for MILEX * manufactured by Cooper Surgical.
[363272]
Cooper surgical sold rptr a diaphragm knowing the gel it has been prescribed with for decades shur-gel has been discontinued. Their customer relations department told rptr to use "whatever" gel they could find. Not only is this practicing medicine without a license but it goes completely against the package insert for the milex diaphragm. Two pharmacies say there is no therapeutic equivalent to shur-gel and that no other product has been tried with a silicone diaphragm. There is nothing commercially available to use with this product. In addition their reference to use whatever is clinically misleading to non-health care workers and is going to lead to an increased rate of pregnancy which they will just brush off to the "diaphragm is not perfect. " rptr is a physician and was planning to use the silicone diaphragm as a back up method since rptr is latex allergic but currently it is useless even for that.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1032770 |
| MDR Report Key | 549236 |
| Date Received | 2004-07-19 |
| Date of Report | 2004-07-19 |
| Date of Event | 2004-07-02 |
| Date Added to Maude | 2004-10-20 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| 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 | MILEX |
| Generic Name | WIDESEAL DIAPHRAGM |
| Product Code | HDW |
| Date Received | 2004-07-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 770304 |
| ID Number | SIZE 75 |
| Device Expiration Date | 2012-12-20 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 538725 |
| Manufacturer | COOPER SURGICAL |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2004-07-19 |