MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-01-31 for UNKNOWN manufactured by Unk.
[2470290]
During surgical repair of multiple full-thickness eyelid lacerations and superior canalicular laceration of the right eye (caused by a dog bite), the tip of the nasolacrimal probe retrieval hook broke and became embedded in the right inferior turbinate. The lacerations were repaired and the child was discharged with follow-up instructions and appointments.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2435879 |
MDR Report Key | 2435879 |
Report Source | 99 |
Date Received | 2012-01-31 |
Date of Report | 2011-04-28 |
Date of Event | 2011-03-05 |
Date Facility Aware | 2011-03-05 |
Report Date | 2011-04-28 |
Date Added to Maude | 2012-02-02 |
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 | RISK MANAGER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 0 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | UNKNOWN |
Generic Name | CRAWFORD RETRIEVING HOOK |
Product Code | HNL |
Date Received | 2012-01-31 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | NA |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | UNK |
Manufacturer Address | UNK UNK |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2012-01-31 |