MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-03-16 for 5 CS MIRR. FS DOUBLE SIDE 67-720 manufactured by .
[1434510]
Dental facility reported that on friday (b)(6)2010, a (b)(6) child swallowed a mirror that was used to retract the cheek/tongue during a routine sealant procedure. The mirror fell out of its frame. Child was sent to the urgent care center to be evaluated. Urgent care center advised parent to go to the hospital emergency room where the child was sedated for removal of mirror from the esophagus. Doctor contacted the mother on saturday (b)(6)2010 to f/u on child's condition. Child is fine.
Patient Sequence No: 1, Text Type: D, B5
[8667201]
The investigators report the condition of returned instrument as used. It was confirmed that the returned mirror has both sides separated from the frame. There is residual adhesive on the mirror frame. The reflective surface of the glass is scratched, spotted, and worn. The root cause could not be determined. Based on the reported info and the investigation results provided, integra considers this complaint closed. Future incidents of this nature will be documented for recurrence and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2010-00001 |
| MDR Report Key | 1637622 |
| Report Source | 06 |
| Date Received | 2010-03-16 |
| Date of Report | 2010-03-16 |
| Date of Event | 2010-02-19 |
| Date Mfgr Received | 2010-02-22 |
| Date Added to Maude | 2010-09-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE, RN, BSM |
| Manufacturer Street | 311 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5 CS MIRR. FS DOUBLE SIDE |
| Generic Name | M52 - HYGIENE/PERIDONTAL |
| Product Code | EAX |
| Date Received | 2010-03-16 |
| Catalog Number | 67-720 |
| Lot Number | E46804111 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-16 |