MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 2012-01-18 for MCK SYR EAR COMP 4OZ O-G 43-2-251 manufactured by Integra York, Pa Inc..
[2565966]
On (b)(6)_2012, the nurse manager reported the pt had her ears irrigated on (b)(6) 2011 for the removal of ear wax. The physician was able to irrigate the pt's left ear with 350 cc of warm water without incident. When she irrigated the right ear, she used 2000 cc of warm water, the syringe seemed stiff and the plunger broke and the tip of the syringe pushed into the pt's right ear causing immediate pain. The pt had a vasovagal reaction and felt nauseated. Her blood pressure was 114. 82 and her pulse was 88. The pt's right ear was bleeding and she was immediately sent to to seen by an ent physician. The nurse had no additional information surrounding the outcome.
Patient Sequence No: 1, Text Type: D, B5
[9585417]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2012-00011 |
| MDR Report Key | 2423058 |
| Report Source | 05,06,08 |
| Date Received | 2012-01-18 |
| Date of Report | 2012-01-18 |
| Date of Event | 2011-12-23 |
| Date Mfgr Received | 2012-01-16 |
| Date Added to Maude | 2012-01-23 |
| 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 | 0 |
| Manufacturer Contact | CAREN FERNANDEZ |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCK SYR EAR COMP 4OZ O-G |
| Generic Name | M11 - ENT |
| Product Code | KCP |
| Date Received | 2012-01-18 |
| Catalog Number | 43-2-251 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-18 |