MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-01-06 for CODMAN VARIABLE DEPTH DRILL GUIDE UNK NA manufactured by Johnson & Johnson Professional, Inc..
[205893]
The tip of the guide broke off during the procedure and lodged in the spine, subsequently causing a laceration to the posterior wall of the esophagus, vocal cord paralysis, and damage to the vagal nerve. As a result of vagal nerve damage pt developed reflux esophagitis, "fits of aspiration," coughing and later bi-inguinal hernias. Device tip was surgically retrieved 2 days post-op. The mfr was served with a lawsuit and stated that they were never informed of the incident by the facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1017863 |
| MDR Report Key | 257733 |
| Date Received | 2000-01-06 |
| Date of Report | 2000-01-06 |
| Date of Event | 1997-11-21 |
| Date Added to Maude | 2000-01-11 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN VARIABLE DEPTH DRILL GUIDE |
| Generic Name | DRILL GUIDE |
| Product Code | HXY |
| Date Received | 2000-01-06 |
| Model Number | UNK |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 249588 |
| Manufacturer | JOHNSON & JOHNSON PROFESSIONAL, INC. |
| Manufacturer Address | 325 PARAMOUNT DR RAYNHAM MA 02767 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-01-06 |