FDA Adverse Event
Injury
Summary report: N
TOPCARE HEALTH
MDR report key: 15543662
·
Received October 5, 2022
Report
- Report Number
- 1038758-2022-00040
- Event Type
- Injury
- Date Received
- October 5, 2022
- Date of Event
- September 13, 2022
- Report Date
- October 5, 2022
- Manufacturer
- JIANGSU NANFANG MEDICAL CO. LTD.
- Product Code
- KGX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
ASO 10/03/2022 MANUFACTURER COMPLETED THEIR INVESTIGATION WITH NO ISSUES FOUND. IN ADDITION, ASO REVIEWED RECORDS OF SATISFACTORY BIOCOMPATIBILITY TESTS FOR THIS TYPE OF PRODUCT WITH NO ISSUES NOTED.
Description of Event or Problem · 0
CONSUMER REPORTED ON (B)(6) 2022 THAT PRODUCT CAUSED A RASH. CONSUMER INFORMED THAT HE SOUGHT MEDICAL ATTENTION. DOCTOR RECOMMENDED ANTIBIOTIC OINTMENT ON THE AREA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2592817 | TOPCARE HEALTH | WATERPROOF ADHESIVE TAPE | KGX | JIANGSU NANFANG MEDICAL CO. LTD. | UPC#036800118911 | 2423-21150 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other |