MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-03-28 for ZERTYL P-METER P/METER DOPPLER FLOW METER manufactured by Zertyl Medical, Inc..
[20474746]
User error - not adverse event and/or product problem. Product was placed directly on an abdominal graft during surgery. Product is labeled and sold as non-sterile for topical use. Pt was reportedly released from hospital without any adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 39749-1995-09001 |
| MDR Report Key | 22095 |
| Date Received | 1995-03-28 |
| Date of Report | 1995-03-21 |
| Date Facility Aware | 1995-03-01 |
| Report Date | 1995-03-21 |
| Date Reported to FDA | 1995-03-21 |
| Date Reported to Mfgr | 1995-03-01 |
| Date Added to Maude | 1995-06-01 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZERTYL P-METER |
| Generic Name | PULSE BLOOD FLOW MONITOR (DOPPLER) |
| Product Code | BZH |
| Date Received | 1995-03-28 |
| Model Number | P/METER DOPPLER FLOW METER |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22184 |
| Manufacturer | ZERTYL MEDICAL, INC. |
| Manufacturer Address | 114 W. FRANKLIN AVENUE SUITE K-19 PENNINGTON NJ 08534 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-03-28 |