MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-11-14 for KIMBERLY CLARK AND ACS * CBMN 17A manufactured by Kimberly Clark.
[21388519]
Hole in wrap around basin, which was not noticed until end of procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1030221 |
| MDR Report Key | 496705 |
| Date Received | 2003-11-14 |
| Date of Report | 2003-10-31 |
| Date of Event | 2003-10-29 |
| Date Added to Maude | 2003-11-24 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KIMBERLY CLARK AND ACS |
| Generic Name | WRAP ON BASIN WITHIN CUSTOM MINOR PACK |
| Product Code | FNY |
| Date Received | 2003-11-14 |
| Model Number | * |
| Catalog Number | CBMN 17A |
| Lot Number | 707031 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 485433 |
| Manufacturer | KIMBERLY CLARK |
| Manufacturer Address | 1400 HOLCOMBRIDGE RD ROSWELL GA 30076 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-11-14 |