MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2013-10-21 for ORTHOPEDIC 2POUND/1POUND MALLET KM46666 manufactured by Kmedic Gmbh, Pilling Weck, Teleflex Medical Germany.
[16799908]
The complaint was reported as: complaint alleges: "after four months the condition and shape of the mallets have deformed, and bitted around the edges of the mallet heads. Concerned customer mentioned that some bits of the mallets may have fallen inside the patient however there has been no reports of this". There was no medical intervention. Patient condition listed as fine.
Patient Sequence No: 1, Text Type: D, B5
[16943264]
Device sample has been received by manufacturer, but investigation is incomplete at time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005236665-2013-00008 |
| MDR Report Key | 3537202 |
| Report Source | 01,07,08 |
| Date Received | 2013-10-21 |
| Date of Report | 2013-10-01 |
| Date of Event | 2013-09-30 |
| Date Mfgr Received | 2013-10-01 |
| Date Added to Maude | 2014-01-23 |
| 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 |
| Manufacturer Street | TELEFLEX MEDICAL |
| Manufacturer City | GAENSAECKER 36 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 | 2013-10-21 |
| Returned To Mfg | 2013-10-11 |
| Catalog Number | KM46666 |
| Lot Number | B0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KMEDIC GMBH, PILLING WECK, TELEFLEX MEDICAL GERMANY |
| Manufacturer Address | GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-21 |