MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2013-10-28 for ORTHOPEDIC 2POUND/1POUND MALLET KM46666 manufactured by Kmedic Gmbh, Pilling Weck, Teleflex Medical.
[4125050]
The complaint was reported as: complaint alleges: during a total joint procedure, the head flew off the shaft of the instrument. There was no medical intervention. No pt or medical staff injury reported.
Patient Sequence No: 1, Text Type: D, B5
[11458447]
Device sample has not been rec'd by mfr in time for this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005236665-2013-00010 |
| MDR Report Key | 3532515 |
| Report Source | 01,06,07 |
| Date Received | 2013-10-28 |
| Date of Report | 2013-10-10 |
| Date of Event | 2013-09-30 |
| Date Mfgr Received | 2013-10-10 |
| Date Added to Maude | 2014-01-29 |
| 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 | ELAINE BURKLE, RN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334957 |
| Manufacturer G1 | KMEDIC EUROPE GMBH, PILLING WECK, 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 | ORTHOPEDIC 2POUND/1POUND MALLET |
| Generic Name | ORTHOPEDIC MALLET |
| Product Code | GFJ |
| Date Received | 2013-10-28 |
| Catalog Number | KM46666 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KMEDIC GMBH, PILLING WECK, TELEFLEX MEDICAL |
| Manufacturer Address | GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-28 |