MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-10-04 for PROSEC UMBILICAL CLAMP * manufactured by Prosec Protection Systems.
[200128]
Umbilical clamp that houses a security transponder inadvertently came off infant, potentially exposing infant to possible abduction from nursery. Mfr, prosec protection systems, notified.
Patient Sequence No: 1, Text Type: D, B5
[20995729]
Add'l info rec'd from mfr 1/12/01: item #2: letter indicates that the tests data does not support the fact that the clamp was attributable to the adverse events in the medical device report. However, upon notification, prosec immediately replaced all of their stock with a different clamp. In addition, prosec immediately discontinued the sale and distribution of the clamp in question to any hosp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1020105 |
| MDR Report Key | 299530 |
| Date Received | 2000-10-04 |
| Date of Report | 2000-10-04 |
| Date Added to Maude | 2000-10-12 |
| 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 | RISK MANAGER |
| 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 | PROSEC UMBILICAL CLAMP |
| Generic Name | INFANT UMBILICAL CLAMP W/ SECURITY TRANSPONDER DEVICE |
| Product Code | HFW |
| Date Received | 2000-10-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 289928 |
| Manufacturer | PROSEC PROTECTION SYSTEMS |
| Manufacturer Address | 1985 SWARTHMORE AVE STE 7 LAKEWOOD NJ 08701 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-10-04 |