MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-06-02 for BITE BLOCK-MAXI-LATEX-FREE 00712804 manufactured by United States Endoscopy Group, Inc..
[22128231]
The latex-free bite block was used on a pt. It was reported that the strap portion of the bite block touch the side of the pt's face causing an allergic reaction. A topical steroid was used to remedy the reaction.
Patient Sequence No: 1, Text Type: D, B5
[22130848]
A review of trending info conducted by the mfr revealed no other reported issues with this product lot number. Although an allergic reaction was reported, the device in question was discarded and the company is still trying to obtain additional units for our investigation. Therefore, the root cause of the incident has not been definitively determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1528319-2011-00010 |
| MDR Report Key | 2118471 |
| Report Source | 00 |
| Date Received | 2011-06-02 |
| Date of Report | 2011-06-03 |
| Date of Event | 2011-05-06 |
| Date Mfgr Received | 2011-06-01 |
| Date Added to Maude | 2011-06-13 |
| 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 | MR. CRAIG MOORE |
| Manufacturer Street | 5976 HEISELY RD. |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4406394494 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BITE BLOCK-MAXI-LATEX-FREE |
| Generic Name | BITE BLOCK |
| Product Code | JXL |
| Date Received | 2011-06-02 |
| Model Number | 00712804 |
| Catalog Number | 00712804 |
| Lot Number | 36696 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNITED STATES ENDOSCOPY GROUP, INC. |
| Manufacturer Address | 5976 HEISELY RD. MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-06-02 |