FDA Adverse Event
Injury
Summary report: N
CVS HEALTH
MDR report key: 9168740
·
Received October 8, 2019
Report
- Report Number
- 1038758-2019-00044
- Event Type
- Injury
- Date Received
- October 8, 2019
- Report Date
- September 8, 2019
- Manufacturer
- JIANGSU NANFANG MEDICAL CO. LTD.
- Product Code
- KGX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS OF (B)(6) 2019 UNUSED SAMPLES OR LOT NUMBER WERE NOT PROVIDED. ASO HAS REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS AND NOTIFIED THE MANUFACTURER ABOUT THE EVENT.
Description of Event or Problem · 1
ON THE INITIAL REPORT ON (B)(6) 2019 CONSUMER STATED THE TAPE CAUSED HIM ITCHING, BURNING SENSATION AND ABRASION. HE ALSO ADDED THAT UPON REMOVAL HE HAD AN INFECTION IN THE AREA. ON (B)(6) 2019 CONSUMER INFORMED HE SOUGHT MEDICAL ATTENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 961134 | CVS HEALTH | WATERPROOF ADHESIVE TAPE | KGX | JIANGSU NANFANG MEDICAL CO. LTD. | UPC#050428269084 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |