FDA Adverse Event
Injury
Summary report: N
UNKNOWN CHLORAPREP
MDR report key: 12970819
·
Received December 9, 2021
Report
- Report Number
- 3004932373-2021-00530
- Event Type
- Injury
- Date Received
- December 9, 2021
- Date of Event
- November 29, 2021
- Report Date
- December 4, 2021
- Manufacturer
- CAREFUSION 213, LLC 0113
- Product Code
- OJU
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
(B)(4). (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 0
MATERIAL NO: UNKNOWN. BATCH NO: UNKNOWN. IT WAS REPORTED THAT PEDIATRIC BURNS WITH CYANOACRYLATE GLUE. VERBATIM: CHLORAPREP- PEDIATRIC BURNS WITH CYANOACRYLATE GLUE: AN INCONSPICUOUS DANGER. PLEASE FIND ATTACHED FULL TEXT ARTICLE CONTAINING AN ICSR REGARDING CHLORHEXIDINE (OLU), COUNTRY: (B)(6). DOIN: (B)(6) 2021. REFERENCE DETAIL: PEDIATRIC BURNS WITH CYANOACRYLATE GLUE: AN INCONSPICUOUS DANGER CARVALHO C., MARINHO A.S., BARBOSA-SEQUEIRA J., CORREIA M.R., CARVALHO F., BANQUART-LEITÃO J., MORGADO H. JOURNAL OF BURN CARE AND RESEARCH (2021) 42:5 (1047-1049). DATE OF PUBLICATION: 1 SEP 2021.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1870479 | UNKNOWN CHLORAPREP | 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL | OJU | CAREFUSION 213, LLC 0113 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |