MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-12-02 for GARDNER-WELLS TRACTION TONGS COMPLETE VM85-1291 manufactured by Carefusion.
[2320090]
Sales rep reports being told on approximately (b)(6) 2011 that there was an incident during application of the halo involving the screw not functioning properly.? The screw "malfunctioned".? The screw is described as spring-loaded.? On (b)(6) 2011, sales rep reports becoming aware that a death occurred as the result of the screw being tightened to the point of going through the skull and entering the patients brain.? The actual details are sketchy.? Sales rep does not have the clinician's name.? Sales rep was told that the instrument was discarded after the procedure.? There is no sample available.? The instrument is manufactured by instrumed.? Sales rep? Reports he has? Reached out to instrumed to try to obtain the ifu with no response.? User facility has? Requested documentation of? Testing on the spring loaded screw from the manufacturer. Additional information obtained. On (b)(6) 2011 the sales rep was made aware by the user facility that there was in fact no death as a result of the incident. The sales rep was also made aware that the instrument had inadvertently been discarded. The sales rep was not provided any additional information at the time.
Patient Sequence No: 1, Text Type: D, B5
[9570956]
(b)(4). The complaint sample has not been returned for evaluation. To date, the initial reporter has not responded to carefusion's requests for additional information.
Patient Sequence No: 1, Text Type: N, H10
[9682413]
On (b)(6) 2012, the customer provided additional information regarding the incident. The physician placed the gardner-wells traction tongs on the patient and noticed that the screws were not functioning properly. The instrument was removed and a new gardner-wells traction tongs instrument was used for the procedure. During the procedure, the physician noticed a subdural hematoma on the patients head. It was believed that this was caused by the first instrument used on the patient. Unfortunately this instrument was wrapped up after its use and inadvertently discarded. The lot number from the instrument is unknown. No additional information is available from the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2011-00019 |
| MDR Report Key | 2356800 |
| Report Source | 06,07 |
| Date Received | 2011-12-02 |
| Date of Report | 2011-12-02 |
| Date of Event | 2011-10-26 |
| Date Mfgr Received | 2011-10-26 |
| Date Added to Maude | 2011-12-05 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8474737294 |
| Manufacturer G1 | CAREFUSION 2200, INC |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | WAUKEGAN 60085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GARDNER-WELLS TRACTION TONGS COMPLETE |
| Generic Name | TONG, SKULL FOR TRACTION |
| Product Code | HAX |
| Date Received | 2011-12-02 |
| Model Number | VM85-1291 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 1500 WAUKEGAN ROAD MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2011-12-02 |