MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-20 for KORO-FLEX ARCHING DIAPHRAGM manufactured by Schmid Laboratories, Inc..
[11179]
A prescription for the diaphragm was presented to the pharmacy. Rptr took the box off the shelf and broke the seal to check the integrity of the diaphragm. There were no tears or holes in it. Rptr sealed the box and dispensed it to the pt. Rptr received a call from the pt in a day or so saying the diaphragm was not this co's, nor was it a size 80. Rptr told her to bring it in and they would examine the product and exchange her diaphragm for the correct one. The product she brought back was another co's size 65. Rptr doesn't know whether the incorrect product was introduced at the mfr or wholesaler's level.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000649 |
| MDR Report Key | 20276 |
| Date Received | 1995-01-20 |
| Date of Report | 1995-01-20 |
| Date Added to Maude | 1995-03-15 |
| 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 | PHARMACIST |
| 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 ARCHING DIAPHRAGM |
| Generic Name | DIAPHRAGM |
| Product Code | HDW |
| Date Received | 1995-01-20 |
| Lot Number | 441F |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 20163 |
| Manufacturer | SCHMID LABORATORIES, INC. |
| Manufacturer Address | SARASOTA FL 34236 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-01-20 |