MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-04-27 for HEANEY * 8610 manufactured by Codman And Shurtleff, Inc..
[396494]
During surgery the clamp tip broke in the patient. The tip was found and retrieved with the help of x-ray. This extended the length of surgery. After surgery, it was noted that all of the clamp had not been retrieved. X-ray taken showed small tooth of clamp still in patient. The patient was offered surgery to remove the metal but the patient opted to leave the small piece of metal in.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 598131 |
| MDR Report Key | 598131 |
| Date Received | 2005-04-27 |
| Date of Report | 2005-04-27 |
| Date of Event | 2005-04-08 |
| Report Date | 2005-04-27 |
| Date Reported to FDA | 2005-04-27 |
| Date Added to Maude | 2005-05-04 |
| 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 |
| 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 | HEANEY |
| Generic Name | HYSTERECTOMY FORCEPS |
| Product Code | HCZ |
| Date Received | 2005-04-27 |
| Model Number | * |
| Catalog Number | 8610 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 3 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 587969 |
| Manufacturer | CODMAN AND SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 027675199 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2005-04-27 |