MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2008-03-17 for ANCHOR IMPLANT UNK BONE ANCHOR manufactured by Depuy Mitek.
[837485]
A pt called the depuy mitek prod complaint line looking for general info regarding depuy mitek metal anchors. She had bone spurs removed from her heel and achilles tendon re-attached in 1994 using what she believes might have been a mitek metal anchor. Since the metal anchor was implanted she has had a persistant eczema rash at the site ever since.
Patient Sequence No: 1, Text Type: D, B5
[7997674]
The pt does not know the prod code or lot # of the device which prevents a batch history review from being performed. At this time it can not be confirmed the metal device implanted in the pt's foot in 1994 is a mitek metal anchor. The pt indicated the dr has tried antibiotics and topical creams, but the issue has persisted since the device was implanted in 1994. There are currently no plans to remove the anchor from the pt's foot, so the device will not be returned to mitek for eval for any type of root cause analysis. Should add'l inf become available at some future point a f/u medwatch report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221934-2008-00145 |
| MDR Report Key | 1014933 |
| Report Source | 00 |
| Date Received | 2008-03-17 |
| Date of Report | 2008-03-12 |
| Report Date | 2008-03-12 |
| Date Mfgr Received | 2008-03-12 |
| Date Added to Maude | 2008-03-25 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MR RONALD GIANNANGELO |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5089773995 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANCHOR IMPLANT |
| Generic Name | UNKNOWN METAL BONE ANCHOR |
| Product Code | NOV |
| Date Received | 2008-03-17 |
| Catalog Number | UNK BONE ANCHOR |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 984627 |
| Manufacturer | DEPUY MITEK |
| Manufacturer Address | 325 PARAMOUNT DR. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-17 |