MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-04 for WATSON DERMATOME 67.14.35 manufactured by Medicon E.g..
[144269538]
Inspection of the returned device revealed that the bar was deformed, causing misalignment of the blade and resulting in the uneven space and the faulty "0" setting observed by the user. This type of deformation and misalignment would require a strong impact to the device, perhaps due to improper transport or falling. Probable cause identified as improper handling, in addition to lack of routine device inspection by user prior to device reuse.
Patient Sequence No: 1, Text Type: N, H10
[144269539]
During surgical use, the following device problems were observed: existence of a space even when the device is set to "0"; uneven space. It was therefore impossible to produce skin grafts of consistent thickness adequate for transplantation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010099-2019-00006 |
| MDR Report Key | 8580698 |
| Date Received | 2019-05-04 |
| Date of Report | 2019-05-04 |
| Date Mfgr Received | 2017-12-27 |
| Device Manufacturer Date | 2016-11-29 |
| Date Added to Maude | 2019-05-04 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANTON MITTERMUELLER |
| Manufacturer Street | GAENSAECKER 15 |
| Manufacturer City | TUTTLINGEN, 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78532 |
| Manufacturer G1 | MEDICON E.G. |
| Manufacturer Street | GAENSAECKER 15 |
| Manufacturer City | TUTTLINGEN, 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WATSON DERMATOME |
| Generic Name | SKIN GRAFT KNIFE |
| Product Code | EMF |
| Date Received | 2019-05-04 |
| Catalog Number | 67.14.35 |
| Lot Number | 797Y |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICON E.G. |
| Manufacturer Address | GAENSAECKER 15 TUTTLINGEN, 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-04 |