MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-11-23 for PRESERVECYT SOLUTION 70098-001 manufactured by Hologic, Inc.
[60754625]
The responsibly lies with the site/user/clinic to monitor how they handle the product and to perform any necessary investigations or reporting according to the site's procedures as to how an incident like that may have happened. Of course in a case like this where a (b)(6) child is involved, responsibility should also be shared with the parent present for the procedure. It is a circumstance entirely beyond hologic' s control. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[60754626]
A customer in the united states reported that a (b)(6) child who visited the clinic with his mom, attempted to drink a vial of preservcyt solution left on the counter. The child spit it out right away. The mother immediately rinsed out the child's mouth. The child was observed for the rest of the day. Hologic's technical support forwarded material safety data (msds) for preservcyt solution to help them consider the most appropriate action. At this time no further issues have been reported about the boy. On 11/17/2016, it was reported "no further issues have been reported since i last talked to this caller. The boy i was told is fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2016-00276 |
| MDR Report Key | 6123984 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-11-23 |
| Date of Report | 2016-10-27 |
| Date of Event | 2016-10-26 |
| Date Mfgr Received | 2016-10-27 |
| Date Added to Maude | 2016-11-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS SIDRA PIRACHA |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638884 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESERVECYT SOLUTION |
| Generic Name | PRESERVATIVE |
| Product Code | MKQ |
| Date Received | 2016-11-23 |
| Catalog Number | 70098-001 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-23 |