FDA Adverse Event
Injury
Summary report: N
KIWI OMNICUP VACUUM DELIVERY SYSTEM
MDR report key: 7106728
·
Received December 11, 2017
Report
- Report Number
- 1722684-2017-00001
- Event Type
- Injury
- Date Received
- December 11, 2017
- Date of Event
- April 7, 2017
- Report Date
- May 25, 2017
- Manufacturer
- CLINICAL INNOVATIONS, LLC
- Product Code
- HDB
- UDI-DI
- 00814247020659
- PMA / PMN Number
- K981260
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
SUBGALEAL HEMORRHAGES ARE VERY RARE COMPLICATIONS (REPORTED AS LOW AS 4 PER 10,000 TO 8 PER 1,000 DELIVERIES) ASSOCIATED WITH VACUUM-ASSISTED VAGINAL DELIVERIES. RISK FACTORS FOR THIS TYPE OF HEMORRHAGE INCLUDE: NULLIPARITY, MALPOSITION, MISPLACEMENT OF THE CUP, PROLONGED TRACTION EFFORTS, AND POP-OFFS/DETACHMENTS OF THE VACUUM CUP. DEVICE WAS DISCARDED.
Description of Event or Problem · 1
IT WAS REPORTED BY A CLINICAL SPECIALIST THAT THEY "HAVE HAD 3 INCIDENTS IN THE LAST 6 MONTHS OF BABIES WHO HAVE EITHER BEEN DELIVERED BY VENTOUSE (OMNICUP) WHO HAVE HAD A BLEED BETWEEN THE SKULL AND SKIN WHICH IS KNOWN AS A SUBGALEAL BLEED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 885349 | KIWI OMNICUP VACUUM DELIVERY SYSTEM | VACUUM DELIVERY SYSTEM | HDB | CLINICAL INNOVATIONS, LLC | VAC-6000MTE | 161615 | 00814247020659 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 HR | Hospitalization |