MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-22 for IRIS SCISSOR OP5525 manufactured by V. Mueller/ Becton, Dickinson And Company.
[103417908]
Patient having i and d on fifth finger. While md doing dissection the tip of the iris scissor broke off in the patient. The md found the tip and removed it. Abscess of finger of the left hand. I and d by md in office on (b)(6) 2018. No improvement. Sent to hospital on (b)(6) 2018 and admitted for iv antibiotics and betadine soaks. Infection not improving, difficulty moving finger. Surgery on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076050 |
| MDR Report Key | 7366057 |
| Date Received | 2018-03-22 |
| Date of Report | 2018-03-20 |
| Date of Event | 2018-02-25 |
| Date Added to Maude | 2018-03-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IRIS SCISSOR |
| Generic Name | IRIS SCISSOR |
| Product Code | HNF |
| Date Received | 2018-03-22 |
| Model Number | OP5525 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | V. MUELLER/ BECTON, DICKINSON AND COMPANY |
| Manufacturer Address | FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-22 |