FDA Adverse Event
Injury
Summary report: N
CLINIPAD ALCOHOL PADS
MDR report key: 275439
·
Received April 27, 2000
Report
- Report Number
- 1036962-2000-00010
- Event Type
- Injury
- Date Received
- April 27, 2000
- Date of Event
- March 27, 2000
- Report Date
- April 26, 2000
- Manufacturer
- THE CLINIPAD CORP.
- Product Code
- LKB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
PT USING CLINIPAD ALCOHOL PAD FOR 3 WEEKS TO WIPE SITE PRIOR TO INJECTION WITH COPAXONA. INJECTION SITE INFECTION; BLISTERED, RED AND RAW. INFECTION NOTED AT INJECTION SITES WHICH CORRESPOND TO TIMEFRAME OF USE OF CLINIPAD ALCOHOL PADS, (NOT BEFORE, NOT AFTER WHEN USING OTHER PADS). ANTIBIOTIC TREATMENT (ORAL & OINTMENT.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLINIPAD ALCOHOL PADS | ALCOHOL PADS | LKB | THE CLINIPAD CORP. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention |