MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-06-12 for BARD DISPOSABLE BITE BLOCK * 000428 manufactured by Bard Endoscopic Technologies.
[230932]
Upon completion of egd, bite block was removed. Strap caught under pt's head. It sprung back and hit pt's left eye. Pt underwent surgery to eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 399468 |
| MDR Report Key | 399468 |
| Date Received | 2002-06-12 |
| Date of Report | 2002-05-30 |
| Date of Event | 2002-05-06 |
| Date Facility Aware | 2002-05-07 |
| Report Date | 2002-05-30 |
| Date Reported to FDA | 2002-05-30 |
| Date Reported to Mfgr | 2002-05-30 |
| Date Added to Maude | 2002-06-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD DISPOSABLE BITE BLOCK |
| Generic Name | DISPOSABLE BITE BLOCK |
| Product Code | BRW |
| Date Received | 2002-06-12 |
| Model Number | * |
| Catalog Number | 000428 |
| Lot Number | VENDOR CODE #2664 |
| ID Number | ESI #105091 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 388519 |
| Manufacturer | BARD ENDOSCOPIC TECHNOLOGIES |
| Manufacturer Address | 129 CONCORD RD. PO BOX 7031 BILLERICA MA 018217031 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2002-06-12 |