MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-05-09 for KORO-FLEX ARCING DIAPHRAGM * manufactured by London Int'l U S Holdings, Inc..
[63589]
Approx 7 months ago rptr purchased a koro-flex arcing diaphragm and recently it tore. Rptr has been using diaphragms for almost 22 years and never has one torn before. Rptr's doctor ordered a new koro-flex arcing diaphragm. This time rptr examined it carefully before using it and found a flaw. Rptr brought it back to pharmacy, where they asked the pharmacist to check it. Pharmacist agreed that it was flawed. Rptr states they are thoroughly disappointed in product and now frightened that this diaphragm may also break. Pregnancy is a serious matter. Rptr already has two children, (3 years and 8 months) and is not ready to have any others. Rptr is fortunate that they did not get pregnant and grateful that they do not have a medical condition that would make pregnancy a life threatening situation. Rptr hopes co will take the time to fully inspect all of their products before they leave the mfg site, so as to ensure the safety of individuals who purchase this or other products.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001889 |
| MDR Report Key | 95915 |
| Date Received | 1997-05-09 |
| Date of Report | 1997-05-09 |
| Date Added to Maude | 1997-06-06 |
| 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 | 0 |
| 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 | KORO-FLEX ARCING DIAPHRAGM |
| Generic Name | DIAPHRAGM |
| Product Code | HDW |
| Date Received | 1997-05-09 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 94708 |
| Manufacturer | LONDON INT'L U S HOLDINGS, INC. |
| Manufacturer Address | P.O. BOX 4703 SARASOTA FL 342304703 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-05-09 |