MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-02-06 for BITE BLOCK - MAXI - LATEX FREE STRAP 00712804 manufactured by United States Endoscopy Group, Inc..
[15249304]
The user reported three pts were affected by cuts to the lip after endoscopy procedures which included use of bite block - maxi - latex free strap ((b)(4)). These events occurred over the course of a number of months, and the pts were treated with antibiotic ointment. The user stated the bite block was not the known cause of the cuts to the lip, and stated the condition may instead have been the result of factors such as sedation level, care and skill of the person inserting the block, and the condition of the lips prior to the procedure.
Patient Sequence No: 1, Text Type: D, B5
[15552905]
The product was not returned and lot numbers were not provided, consequently there was no examination of the product and no review of the mfg record. A review of complaint history finds no similar report of cuts to the lip associated with this product. The report will be updated if further info becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1528319-2015-00002 |
| MDR Report Key | 4508286 |
| Report Source | 05 |
| Date Received | 2015-02-06 |
| Date of Report | 2015-02-06 |
| Date Mfgr Received | 2015-01-07 |
| Date Added to Maude | 2015-02-12 |
| 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. MICHAEL OLEKSA |
| Manufacturer Street | 5976 HEISLEY RD. |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403586263 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BITE BLOCK - MAXI - LATEX FREE STRAP |
| Generic Name | BITE BLOCK |
| Product Code | JXL |
| Date Received | 2015-02-06 |
| Model Number | 00712804 |
| Catalog Number | 00712804 |
| Lot Number | UNK |
| 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 HEISLEY RD. MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-02-06 |