MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-09-18 for FREER SEPTUM ELEV DBL-END SH/BL 7-3/4IN RH750 manufactured by Carefusion.
[3747034]
Broken medwatch (b)(4) -it was reported that on (b)(6) 2013, a (b)(6) year old morbidly obese patient underwent a kidney procedure with tp tendon advancement for the removal of bone spur. The freer elevator broke off in the left foot during surgery and was recovered by the surgeon. No retained object or fragments noted in the foot. No harm to the patient or staff. The age of? The device is unknown.
Patient Sequence No: 1, Text Type: D, B5
[11105261]
(b)(4). The device is not available for investigation. If additional information becomes available a follow-up mdr will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1923569-2013-00010 |
| MDR Report Key | 3354968 |
| Report Source | 04 |
| Date Received | 2013-09-18 |
| Date of Report | 2013-08-26 |
| Date of Event | 2013-08-05 |
| Date Mfgr Received | 2013-08-26 |
| Date Added to Maude | 2013-12-24 |
| 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 | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628056 |
| Manufacturer G1 | CAREFUSION 2200 INC (ST. LOUIS) |
| Manufacturer Street | 5 SUNNEN DR |
| Manufacturer City | ST. LOUIS 63143 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREER SEPTUM ELEV DBL-END SH/BL 7-3/4IN |
| Generic Name | ELEVATOR, ENT |
| Product Code | KAD |
| Date Received | 2013-09-18 |
| Model Number | RH750 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-18 |