MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-16 for GARDENER-WELLS TRACTION TONG manufactured by Radronics Sales.
[4514]
On april 5, 1993, the patient had a traction tongs applied by a neurosurgeon without complication. On april 6, 1993. The tongs were removed and shortly thereafter both pin sites developed spinal fluid leaks. These sites necessitated a suturing and staple procedure. Device not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, mechanical tests performed. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6320 |
| MDR Report Key | 6320 |
| Date Received | 1993-08-16 |
| Date of Report | 1993-05-05 |
| Date of Event | 1993-04-05 |
| Date Facility Aware | 1993-04-07 |
| Report Date | 1993-05-05 |
| Date Reported to FDA | 1993-05-05 |
| Date Reported to Mfgr | 1993-05-05 |
| Date Added to Maude | 1993-08-31 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GARDENER-WELLS TRACTION TONG |
| Generic Name | NI |
| Product Code | HAX |
| Date Received | 1993-08-16 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 6009 |
| Manufacturer | RADRONICS SALES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-08-16 |