MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-07 for SKLAR? 96-2504C manufactured by Sklar Corporation.
[135359485]
Rn reported a new sterile package of iris scissors was opened and scissors immediately broke causing the nurse to sustain a puncture. There was no serious harm to the nurse or the patient. An employee injury form was completed and the scissors are being returned to the manufacturer by the nursing unit. Manufacturer response for scissors, general, surgical, sklar? (per site reporter). The nursing unit contacted sklar corp directly. A complaint file was opened and the device will be returned for failure analysis. The status is currently unknown, but will be shared when/if it becomes available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8314397 |
| MDR Report Key | 8314397 |
| Date Received | 2019-02-07 |
| Date of Report | 2019-01-30 |
| Date of Event | 2019-01-16 |
| Report Date | 2019-01-30 |
| Date Reported to FDA | 2019-01-30 |
| Date Reported to Mfgr | 2019-02-07 |
| Date Added to Maude | 2019-02-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKLAR? |
| Generic Name | SCISSORS, GENERAL, SURGICAL |
| Product Code | LRW |
| Date Received | 2019-02-07 |
| Model Number | 96-2504C |
| Lot Number | 01198405 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SKLAR CORPORATION |
| Manufacturer Address | 889 SOUTH MATLACK STREET WEST CHESTER PA 19382 US 19382 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-07 |