MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-02-27 for CARDINAL * 46012 - LAR manufactured by Cardinal Healthcare - Distributor.
[17116689]
A female admitted with an intrauterine pregnancy. Pregnancy complicated by pre-term labor. Patient was putting on a new pair of slipper/socks and felt a "something sharp stick her heel. " no apparent skin injury was noted. The patient then removed a piece of silver metal resembling the tip of a sewing machine needle approixmately 1 cm in length.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1042091 |
| MDR Report Key | 823264 |
| Date Received | 2007-02-27 |
| Date of Report | 2007-02-27 |
| Date of Event | 2007-02-24 |
| Date Added to Maude | 2007-03-07 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDINAL |
| Generic Name | CAMEL SLIPPERS LARGE |
| Product Code | FXP |
| Date Received | 2007-02-27 |
| Model Number | * |
| Catalog Number | 46012 - LAR |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 810669 |
| Manufacturer | CARDINAL HEALTHCARE - DISTRIBUTOR |
| Manufacturer Address | * ST. LOUIS MO * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-02-27 |