FDA Adverse Event
Other
Summary report: N
ANCHOR FIX MULTI-PURPOSE COVER TAPE
MDR report key: 604891
·
Received May 19, 2005
Report
- Report Number
- 2939821-2005-00003
- Event Type
- Other
- Date Received
- May 19, 2005
- Date of Event
- May 5, 2005
- Report Date
- May 12, 2005
- Manufacturer
- NORTH COAST MEDICAL, INC.
- Product Code
- KGX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICAL THERAPIST
Narratives
Description of Event or Problem · 1
AFTER RECEIVING TREATMENT TO ALTER PATELLAR (KNEECAP) POSITIONING, PT EXPERIENCED SKIN IRRITATION WHEN ANCHOR FIX UNDERWRAP (ADHESIVE FABRIC TAPE) WAS REMOVED. ACCORDING TO THE PHYSICAL THERAPIST, THERE WAS MINOR RED IRRITATION WITH SMALL BUMPS. ACCORDING TO THE PHYSICAL THERAPIST, THIS ISN'T FAR FROM AN ORDINARY REACTION TO ADHESIVE FABRIC TAPING. PT HAD LEFT ANCHOR FIX ON FOR 2 DAYS BEFORE REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANCHOR FIX MULTI-PURPOSE COVER TAPE | ADHESIVE FABRIC TAPE (UNDERWRAP) | KGX | NORTH COAST MEDICAL, INC. | NC22001-2 | A0416 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other |