FDA Adverse Event
Other
Summary report: N
ANCHOR FIX MULTI-PURPOSE COVER TAPE
MDR report key: 604874
·
Received May 19, 2005
Report
- Report Number
- 2939821-2005-00002
- Event Type
- Other
- Date Received
- May 19, 2005
- Date of Event
- April 27, 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 PHYSICIAN THERAPIST, THERE WAS VERY MINOR IRRITATION AND IT WASN'T SIGNIFICANT ENOUGH TO DISUSE THE PRODUCT. THE PHYSICAL THERAPIST NOTED THAT THIS TYPE OF MINOR REACTION IS COMMON WITH ADHESIVE FABRIC TAPING. THIS PT DID NOT EXPERIENCED ADDITIONAL IRRITATION WITH CONTINUED USE OF THE ANCHOR FIX.
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 | 56 YR | Other |