FDA Adverse Event
Other
Summary report: N
CRANIAL KIT - NO DRUGS
MDR report key: 2582775
·
Received May 18, 2012
Report
- Report Number
- 1722447-2012-00001
- Event Type
- Other
- Date Received
- May 18, 2012
- Report Date
- May 18, 2012
- Manufacturer
- INTEGRA PAIN MGMT
- Product Code
- CAZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE SURGEON OPENED THE CRANIAL ACCESS KIT TO PUT A "VENTRIC" INTO AN INTENSIVE CARE UNIT (ICU) PT, THERE WAS HAIR INSIDE OF THE WRAP. THE PRODUCT WAS NOT USED. THERE WAS NO PT CONTACT. ADD'L CLINICAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRANIAL KIT - NO DRUGS | NA | CAZ | INTEGRA PAIN MGMT | W1109222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |