MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,08 report with the FDA on 2012-05-21 for KMEDIC ORTHO. MALLET 3 LB/2 LB KM46667 manufactured by Kmedic Europe Gmbh.
[2659683]
The event is reported as: alleged issue: "customer called saying that during a case, the head of the mallet broke off of the handle. No pieces fell into the patient and there was no patient injury. " patient current condition is fine.
Patient Sequence No: 1, Text Type: D, B5
[9930680]
Sample received by manufacturer, but investigation is incomplete at time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005236665-2012-00005 |
| MDR Report Key | 2588532 |
| Report Source | 06,07,08 |
| Date Received | 2012-05-21 |
| Date of Report | 2012-05-03 |
| Date of Event | 2012-05-02 |
| Date Mfgr Received | 2012-05-03 |
| Date Added to Maude | 2012-09-25 |
| 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 | JASMINE BORWN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | GAENSAECKER 36 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KMEDIC ORTHO. MALLET 3 LB/2 LB |
| Generic Name | MALLET |
| Product Code | HXL |
| Date Received | 2012-05-21 |
| Returned To Mfg | 2012-05-10 |
| Catalog Number | KM46667 |
| Lot Number | 98/2 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KMEDIC EUROPE GMBH |
| Manufacturer Address | PILLING WECK TELEFLEX MEDICAL GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-21 |