MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2011-04-05 for CO202 BITE BLOCK CO25 manufactured by Encompas Unlimited, Inc..
[1948065]
Device was used in a bronchoscopy procedure. The reporting hospital staff stated they found the bite block big, but did use it. During the procedure, the patient suffered damage/breakage to front teeth.
Patient Sequence No: 1, Text Type: D, B5
[9186575]
If device is put on or taken off too brutally, then device could have an adverse reaction to patients mouth/teeth. Device was redesigned to include a smaller center orifice to help minimize this problem.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056035-2008-00001 |
| MDR Report Key | 2065583 |
| Report Source | 01 |
| Date Received | 2011-04-05 |
| Date of Report | 2011-03-17 |
| Date of Event | 2008-08-08 |
| Date Facility Aware | 2008-08-08 |
| Report Date | 2011-03-17 |
| Date Reported to Mfgr | 2008-08-11 |
| Date Mfgr Received | 2008-04-01 |
| Device Manufacturer Date | 2008-04-01 |
| Date Added to Maude | 2011-04-28 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 Street | 2219 WHITFIELD PARK DR. |
| Manufacturer City | SARASOTA FL 34243 |
| Manufacturer Country | US |
| Manufacturer Postal | 34243 |
| Manufacturer Phone | 9417513385 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CO202 BITE BLOCK |
| Generic Name | ENDOSCOPY BITE BLOCK |
| Product Code | JXL |
| Date Received | 2011-04-05 |
| Model Number | CO202 |
| Catalog Number | CO25 |
| Lot Number | CO202/400/08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENCOMPAS UNLIMITED, INC. |
| Manufacturer Address | SARASOTA FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-04-05 |