MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-10-11 for CORD CLAMP CLIPPER 9441 manufactured by Mabis Healthcare.
[3780092]
Cord clamp clipper broke while nurse attempting to cut the cord clamp. Broken clipper saved for manager. Apparently, this has happened a total of 4 different times with 4 different patients. Diagnosis or reason for use: device is used to cut the umbilical cord clamp from.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5032251 |
| MDR Report Key | 3416227 |
| Date Received | 2013-10-11 |
| Date of Report | 2013-10-10 |
| Date of Event | 2013-10-05 |
| Date Added to Maude | 2013-10-18 |
| 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 | 3 |
| 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 | CORD CLAMP CLIPPER |
| Generic Name | CORD CLAMP CLIPPER |
| Product Code | HFW |
| Date Received | 2013-10-11 |
| Model Number | 9441 |
| Lot Number | 4789920513 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MABIS HEALTHCARE |
| Manufacturer Address | WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-11 |