FDA Adverse Event
Injury
Summary report: N
DEX II BE 5X18 SC T5 2/0 DT
MDR report key: 800082
·
Received December 29, 2006
Report
- Report Number
- 9681850-2006-00011
- Event Type
- Injury
- Date Received
- December 29, 2006
- Date of Event
- August 13, 2006
- Report Date
- August 15, 2006
- Manufacturer
- GOSPORT - USS
- Product Code
- GAN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DURING A ROUTINE REVIEW OF OUR COMPLAINTS, THIS FTR WAS RE-EVALUATED. BECAUSE THE INFO AVAILABLE FOR THE EVENT DESCRIPTION IS INSUFFICIENT TO SUPPORT A CONCLUSION THAT AN ADVERSE EVENT DID NOT OCCUR, THE COMPLAINT WILL BE REPORTED TO THE FDA.
Description of Event or Problem · 1
REPORTEDLY, DURING A NEURO-BACK PROCEDURE, THE NEEDLE BROKE OFF IN THE PT. THE NEEDLE COULD NOT BE FOUND UNTIL AN X-RAY WAS PERFORMED. THE NEEDLE TIP WAS FOUND AND THE PT WAS CLOSED WITHOUT COMPLICATIONS. NO ADD'L INFO WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEX II BE 5X18 SC T5 2/0 DT | ABSORBABLE SYNTHETIC SUTURE | GAN | GOSPORT - USS | * | E6D0828C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |