MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-05-01 for UMBILICAL CORD CLAMP 460-00 manufactured by Unomedical Ltd..
[4528552]
Product does not grip tightly enough and does not stop the blood flow. This has caused a baby to need blood transfusion in intensive care.
Patient Sequence No: 1, Text Type: D, B5
[11786818]
Based on the available information, this event is deemed a serious injury and the device was used on a pt. No additional pt/event details have been provided to date. Should additional information become available a follow-up report will be submitted. A return sample for evaluation is not expected. Convatec will continue to observe for trends regarding these complaint types. This mdr is being reported as a result of a retrospective review of complaint records conducted by convatec for complaints received from may 1, 2011- september 30, 2013. Note: the actual date of event is unknown, so the date used was the date convatec became aware.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007966929-2014-00015 |
| MDR Report Key | 3812672 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-05-01 |
| Date of Report | 2011-05-17 |
| Date of Event | 2011-05-17 |
| Date Mfgr Received | 2011-05-17 |
| Date Added to Maude | 2014-05-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW WALENCIAK |
| Manufacturer Street | 200 HEADQUARTERS PARK DRIVE |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9083779293 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UMBILICAL CORD CLAMP |
| Generic Name | OPERATION ACCESSORIES |
| Product Code | HFW |
| Date Received | 2014-05-01 |
| Model Number | 460-00 |
| Catalog Number | 460-00 |
| Lot Number | 1103 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL LTD. |
| Manufacturer Address | ZAVODSKAYA STREET 50 FANIPOL DZERZHINSK DISTRICT MINSK REGION 222750 BO 222750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-05-01 |