FDA Adverse Event
Injury
Summary report: N
BIOGEL SURGEONS SIZE 7.0
MDR report key: 4223493
·
Received October 29, 2014
Report
- Report Number
- 3004763499-2014-00019
- Event Type
- Injury
- Date Received
- October 29, 2014
- Date of Event
- August 24, 2014
- Report Date
- October 29, 2014
- Manufacturer
- MOLNLYCKE HEALTHCARE
- Product Code
- KGO
- PMA / PMN Number
- K970924
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
(B)(4). RECEIVED REPORT FROM FACILITY STATING THAT A DR DOING R. BREAST ABCESS, DOUBLE GLOVED, 7.5 GREEN GLOVE UNDER, 7 SURGEONS OUTER. LEFT GLOVE HOLE INDEX FINGER. FEELING IN ABCESS CAVITY HOLE DEVELOP. UNABLE TO OBTAIN ADDITIONAL INFO FROM FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 692603 | BIOGEL SURGEONS SIZE 7.0 | KGO | MOLNLYCKE HEALTHCARE | NA | 14 D293 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |