MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-26 for UMBILICAL CORD CLAMP 9423 manufactured by Hollister Incorporated.
[125149704]
Umbilical cord clamp came off a baby. Father caught it and bleeding was minimal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8008632 |
| MDR Report Key | 8008632 |
| Date Received | 2018-10-26 |
| Date of Report | 2018-11-28 |
| Date of Event | 2018-09-26 |
| Date Facility Aware | 2018-10-30 |
| Report Date | 2008-09-26 |
| Date Reported to FDA | 2008-09-26 |
| Date Reported to Mfgr | 2018-11-28 |
| Date Added to Maude | 2018-10-26 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UMBILICAL CORD CLAMP |
| Generic Name | UMBILICAL CORD CLAMP |
| Product Code | HFW |
| Date Received | 2018-10-26 |
| Model Number | 9423 |
| Catalog Number | 9423 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER INCORPORATED |
| Manufacturer Address | 1502 EAST LAHARPE KIRKSVILLE MO 63501 US 63501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-26 |