FDA Adverse Event
Injury
Summary report: N
BENEHOLD MEDICAL TAPE STRIPS
MDR report key: 2662710
·
Received July 17, 2012
Report
- Report Number
- 3005360738-2012-00004
- Event Type
- Injury
- Date Received
- July 17, 2012
- Date of Event
- June 22, 2012
- Report Date
- July 17, 2012
- Manufacturer
- AVERY DENNISON BELGIE, BVBA
- Product Code
- KGX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT COMPLAINT INVESTIGATION WAS CONCLUDED AND SHOWED THAT THE PRODUCT HAD MET SPECIFICATIONS.
Description of Event or Problem · 1
PRODUCT USED TO ANCHOR VENOUS NEEDLE DURING DIALYSIS THERAPY. VENOUS NEEDLE BECAME DISLODGED DUE TO TAPE NOT ADHERING SUFFICIENTLY. PT LOST 150CC OF BLOOD. TREATMENT WAS STOPPED. THE FACILITY INDICATED THAT THE PT WAS NOT INJURED AND NO OTHER INTERVENTION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BENEHOLD MEDICAL TAPE STRIPS | TAPE ON A SHEET | KGX | AVERY DENNISON BELGIE, BVBA | 9533186 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention | FISTULA NEEDLE |