MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-11-25 for UMBILICAL CLAMP * 9423 manufactured by Hollister, Inc.
[16617111]
When the umbilical cord was clamped at the time of delivery, a small area (1-2 cm)1-2 centimeters of skin was actually caught in the clamp. About 5 hours after delivery it was discovered, another clamp was put higher on the cut cord, the original clamp was then removed and triple dye applied to the cord.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 555743 |
| MDR Report Key | 555743 |
| Date Received | 2003-11-25 |
| Date of Report | 2003-11-25 |
| Date of Event | 2003-10-31 |
| Report Date | 2003-11-25 |
| Date Reported to FDA | 2003-11-25 |
| Date Added to Maude | 2004-11-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | UMBILICAL CLAMP |
| Generic Name | UMBILICAL CLAMP |
| Product Code | HFW |
| Date Received | 2003-11-25 |
| Model Number | * |
| Catalog Number | 9423 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 545392 |
| Manufacturer | HOLLISTER, INC |
| Manufacturer Address | 2000 HOLLISTER DRIVE LIBERTYVILLE IL 60048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-11-25 |