MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-01 for UMBILICAL CORD CLAMP D 9411 manufactured by Hollister Incorporated.
[90782715]
Patient Sequence No: 1, Text Type: N, H10
[90782716]
Cord clamp applied. Upon moving infant to the warmer, cord clamp became restricted against another object and tore umbilical cord, causing bleeding to infant at umbilical cord site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6993317 |
| MDR Report Key | 6993317 |
| Date Received | 2017-11-01 |
| Date of Report | 2017-12-08 |
| Date of Event | 2016-12-05 |
| Date Facility Aware | 2017-11-08 |
| Report Date | 2017-09-29 |
| Date Reported to FDA | 2017-09-29 |
| Date Reported to Mfgr | 2017-09-29 |
| Date Added to Maude | 2017-11-01 |
| 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 | RISK MANAGER |
| 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 | CLAMP, UMBILICAL |
| Product Code | HFW |
| Date Received | 2017-11-01 |
| Model Number | D 9411 |
| Catalog Number | D 9411 |
| Lot Number | NI |
| ID Number | 0050 |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-11-01 |