MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-06 for JARIT MOUTH GAG AL11 manufactured by Integra York Pa Inc..
[144459072]
A mouth gag was used during a tonsillectomy procedure. After the procedure was completed, the surgeon inspected the adenoids and saw a small metal screw. It was removed by the surgeon. Upon inspection of the mouth gag, it was identified to be missing a small screw. The mouth gag in question was manufactured by jarit. During a tonsillectomy the jarit mouth gag was used. Following the tonsillectomy, the surgeon went back in and looked one more time at the adenoids. During this inspection, he saw a small screw. The screw was retrieved and upon inspection of the mouth gag, it was noted that the screw was missing on the instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086422 |
| MDR Report Key | 8587271 |
| Date Received | 2019-05-06 |
| Date of Report | 2019-04-17 |
| Date of Event | 2019-04-04 |
| Date Added to Maude | 2019-05-07 |
| 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 | JARIT MOUTH GAG |
| Generic Name | MOUTH GAG |
| Product Code | KBN |
| Date Received | 2019-05-06 |
| Returned To Mfg | 2019-04-11 |
| Model Number | AL11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| 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 | 1. Required No Informationntervention | 2019-05-06 |