MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2002-06-12 for BARD DISPOSABLE BITE BLOCK 61 000428 manufactured by Bard Endoscopic Technologies/cr Bard.
[277194]
Per sales rep, during procedure the staff tried to remove the bit block with kelly clamps with the latex strap in place. The device "sling-shot" and hit the pt in the eye. Per medwatch report, upon completion of egd, bite block was removed. The strap caught under the pt's head. It sprung back and hit the pt's left eye. Pt underwent surgery to eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1223688-2002-00061 |
| MDR Report Key | 399472 |
| Report Source | 00 |
| Date Received | 2002-06-12 |
| Date of Report | 2002-05-16 |
| Date of Event | 2002-05-01 |
| Date Facility Aware | 2002-05-07 |
| Report Date | 2002-06-12 |
| 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 | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NANCY CUTINO |
| Manufacturer Street | 129 CONCORD ROAD BLDG #3 |
| Manufacturer City | BILLERICA MA 01821 |
| Manufacturer Country | US |
| Manufacturer Postal | 01821 |
| Manufacturer Phone | 9786638989 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD DISPOSABLE BITE BLOCK |
| Generic Name | BITE BLOCK |
| Product Code | MNK |
| Date Received | 2002-06-12 |
| Model Number | 61 000428 |
| Catalog Number | 61 000428 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 388523 |
| Manufacturer | BARD ENDOSCOPIC TECHNOLOGIES/CR BARD |
| Manufacturer Address | 129 CONCORD RD., BLDG. 3 BILLERICA MA 01821 US |
| Baseline Brand Name | BARD DISPOSABLE BITE BLOCK |
| Baseline Generic Name | BITE BLOCK |
| Baseline Model No | 61 000428 |
| Baseline Catalog No | 61 000428 |
| Baseline ID | NA |
| Baseline Device Family | ACCESSORIES |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 48 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K833491 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2002-06-12 |