KIT,APTIMA CMB2 SWAB SPEC COLL 50PK CE
Received Jun 6, 2017 · Event occurred May 9, 2017
Report 2024800-2017-00017 · MDR key 6615149
Device
Product problems
- Use of Device Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
(B)(6) (CUSTOMER) CALLED HOLOGIC TECHNICAL SUPPORT TO FIND OUT WHAT IS IN THE APTIMA TRANSPORT MEDIA FOR THE UNISEX SWAB COLLECTION KIT. SHE DESCRIBED THAT A CHILD WAS IN THE OFFICE WITH THE MOTHER. THE CHILD GRABBED THE COLLECTION DEVICE WHILE IT WAS BEING PREPARED FOR COLLECTION AND LIKELY INGESTED A SMALL AMOUNT OF THE LIQUID. HOLOGIC TS DIRECTED MARY TO THE SAFETY DATA SHEET ON HOLOGIC WEBSITE. WHICH STATED UNDER FIRST AID MEASURES: INGESTION- CLEAN MOUTH WITH WATER AND DRINK AFTERWARDS PLENTY OF WATER. IF SYMPTOMS PERSIST, CALL A PHYSICIAN. MARY PRINTED THE SAFETY DATA SHEET FOR THE CHILD'S MOTHER WHO WAS NOT CONCERNED AS THE CHILD LIKELY DID NOT INGEST MUCH LIQUID AND ACCORDING TO THE SDS, THE MATERIAL WAS NOT HAZARDOUS. NO FORMS WERE SUBMITTED FOR THE INCIDENT BY THE PATIENT'S MOTHER. PER SDS, CHILD'S MOUTH WAS RINSED WITH WATER AND CHILD WAS GIVEN WATER TO DRINK. CUSTOMER HAS NOT CALLED WITH ANY ADDITIONAL QUESTIONS OR TO VOICE ANY ADDITIONAL CONCERNS.