MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-08-13 for CURITY manufactured by Tyco Health Care Group.
[674136]
Customer called to report that nylon barrier of nursing pad torn/pulled apart into small pieces. She was concerned about her baby, that what if the baby swallowed the pieces. Although, not happened. Customer stated that she has kept the suspect device for investigation if needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5003365 |
| MDR Report Key | 893029 |
| Date Received | 2007-08-13 |
| Date of Report | 2007-08-13 |
| Date Added to Maude | 2007-08-20 |
| 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 | 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 | CURITY |
| Generic Name | NURSING PAD |
| Product Code | NTC |
| Date Received | 2007-08-13 |
| ID Number | REF# 47189-500000-20 |
| Operator | HEALTH PROFESSIONAL |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 873745 |
| Manufacturer | TYCO HEALTH CARE GROUP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-13 |