MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,08 report with the FDA on 2009-02-24 for 11 manufactured by Jai Surgicals Ltd..
[18525542]
The physician held the scalpel upside down, so when he slid the retraction mechanism, he opened the contaminated blade into the palm of his hand. Scalpel was somewhat new to physician. Facility has suggested improving the markings on the scalpel handle which were difficult to read under the low light conditions.
Patient Sequence No: 1, Text Type: D, B5
[18683935]
The scalpel was supplied to user as part of a kit. As jai does not manufacture the kit, we are not aware of how the scalpel is presented. There was no information as whether the facility has a programm for training users. Whilst the product is not considered as defective, action is being taken to evaluate how improvements can be made.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8044030-2009-00001 |
| MDR Report Key | 2609340 |
| Report Source | 04,08 |
| Date Received | 2009-02-24 |
| Date of Report | 2009-02-14 |
| Date of Event | 2009-01-20 |
| Date Facility Aware | 2009-01-20 |
| Report Date | 2009-01-23 |
| Date Mfgr Received | 2009-01-20 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2012-06-12 |
| 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 | 3 |
| Manufacturer Contact | R KUMAR |
| Manufacturer Street | SP-146 (L), RIICO INDUSTRIAL AREA |
| Manufacturer City | BHIWADI, DIST-ALWAR, RAJASTHAN |
| Manufacturer Country | IN |
| Manufacturer Phone | 244338888 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SAFETY SCALPELS |
| Product Code | EME |
| Date Received | 2009-02-24 |
| Model Number | 11 |
| Lot Number | 6114 |
| ID Number | 863573 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JAI SURGICALS LTD. |
| Manufacturer Address | B-3 INFOCITY, SECTOR 33-34 GURGAON IN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-02-24 |