MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-30 for MEDICAL VACUUM PUMP manufactured by Dr. Joel Kaplan Inc.
[4684984]
About 6 months earlier, pt purchased a medical vacuum pump but it had a malfunction. After contacting the manufacturer, a replacement was sent. So far all has been well until last thursday ((b)(6) 2014). After using the device and was about to put it away, the gauge fell off. Manufacturer was again contacted but this time they refused to send a replacement claiming that the device wasn't bought directly from them. Pt has suffered no injuries but would like a refund.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036431 |
| MDR Report Key | 3846084 |
| Date Received | 2014-05-30 |
| Date of Report | 2014-05-30 |
| Date of Event | 2014-05-22 |
| Date Added to Maude | 2014-06-04 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICAL VACUUM PUMP |
| Generic Name | MEDICAL VACUUM PUMP |
| Product Code | LKY |
| Date Received | 2014-05-30 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DR. JOEL KAPLAN INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-30 |