MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2020-01-13 for 74.336.14 manufactured by Dimeda Instrumente Gmbh.
[174840972]
At all relevant times, (b)(6) was a podiatrist employed at the (b)(6) medical center in (b)(6). On (b)(6) 2015, (b)(6) was using the instrument while treating a patient at the (b)(6) medical center. During the course of the treatment, the instrument suddenly and unexpectedly broke apart in (b)(6) hand. As a result of the defective nature of the instrument. (b)(6) suffered an injury to his right hand, requiring various surgeries and resulting in significant and permanent pain and discomfort.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002806816-2020-00001 |
| MDR Report Key | 9580148 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2020-01-13 |
| Date of Report | 2020-01-13 |
| Date of Event | 2015-08-12 |
| Date Mfgr Received | 2019-11-04 |
| Date Added to Maude | 2020-01-13 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ARTUR DUKART |
| Manufacturer Street | GANSACKER 58 |
| Manufacturer City | TUTTLINGEN, BADEN-WURTTEMBERG 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78532 |
| Manufacturer G1 | DIMEDA INSTRUMENTE GMBH |
| Manufacturer Street | GANSACKER 58 |
| 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 |
| Generic Name | NAIL NIPPER 14CM 5-1/2", WITH LOCK, CONCAVE BLADES (ARTICLE NO.: 74.336.14) |
| Product Code | GFA |
| Date Received | 2020-01-13 |
| Catalog Number | 74.336.14 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIMEDA INSTRUMENTE GMBH |
| Manufacturer Address | GANSACKER 58 TUTTLINGEN, 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2020-01-13 |