MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-02-23 for DISPOSABLE MYRINGOTOMY KNIFE 130716 manufactured by Gyrus Ent Llc.
[21325031]
Device is packaged with a tip protector to protect the sharp end while packaged and while removing from packaging. The description from the user indicates that the knife had been in use and was being handled. There is no indication of a malfunction or defect. No other reports for this lot. Lot is no longer on hand. No other reports for this item for the last 4 years.
Patient Sequence No: 1, Text Type: N, H10
[21370803]
Cut finger, blood borne pathogen exposure. Nurse was assisting with scrub in operating room during a bmt procedure, the surgeon put down the myringotomy knife and the nurse went to put the knife back and struck herself in the finger with it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037007-2010-00002 |
| MDR Report Key | 1615199 |
| Report Source | 06 |
| Date Received | 2010-02-23 |
| Date of Report | 2010-02-23 |
| Date of Event | 2010-02-11 |
| Date Mfgr Received | 2010-02-17 |
| Device Manufacturer Date | 2009-07-01 |
| Date Added to Maude | 2010-03-01 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR DOLAN MILLS |
| Manufacturer Street | 2925 APPLING RD. |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal | 38133 |
| Manufacturer Phone | 9013730200 |
| Manufacturer G1 | GYRUS ENT LLC |
| Manufacturer Street | 2925 APPLING RD. |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38133 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE MYRINGOTOMY KNIFE |
| Product Code | JYP |
| Date Received | 2010-02-23 |
| Catalog Number | 130716 |
| Lot Number | 0925221063 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ENT LLC |
| Manufacturer Address | BARTLETT TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-02-23 |