MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-03 for NOVO SURGICAL MCIVOR MOUTH GAG 4553-20 manufactured by Novo Surgical Inc..
[146535117]
Novo surgical started its preliminary investigation by obtaining additional information from the user/facility and requesting that the affected products be returned. The returned products were evaluated by novo surgical's quality assurance for their tensile strength to determine if the products met specification. Once the frames were secured properly to the handles, the evaluated devices were able to withstand force in significant excess of what would typically be encountered in surgery. No non-conformities were observed with these devices. Novo surgical identified no corrective actions. It is possible that the frame was not affixed securely to the handle at the time it came apart and/or that the use of an adult frame on a pediatric patient contributed to the injury as significantly more pressure would need to be applied to fit an adult gag into the mouth of a pediatric patient. A device history review uncovered no previous recorded quality problems or complaints associated with this item.
Patient Sequence No: 1, Text Type: N, H10
[146535118]
Novo surgical inc. Received a sus voluntary event report from the fda (report mw5084100) notifying it of a mdr submitted by a user/facility with regards to a mcivor mouth gag (item no. 4553-20) supplied by novo surgical. The fda correspondence dated february 27, 2019 was delivered via postal mail and received by novo surgical on march 6, 2019. This was the first notification to novo surgical of this complaint. This product is comprised of two parts (a frame and handle) that are to be assembled together with two detachable screws when in use. The product may be disassembled during sterilization. In the sus voluntary event report, the user/facility had indicated that the item came apart as it was being positioned in a pediatric patient's mouth and knocked out one of the patient's front top incisors and significantly loosened another. User/facility also reported that one of the screws of the mouth gags was found to be missing and not recovered and that x-ray confirmed that the patient did not swallow the screw.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008770252-2019-00001 |
| MDR Report Key | 8480591 |
| Date Received | 2019-04-03 |
| Date of Report | 2019-04-03 |
| Date of Event | 2019-02-07 |
| Date Mfgr Received | 2019-03-06 |
| Date Added to Maude | 2019-04-03 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | RUPANSHI NAIK |
| Manufacturer Street | 700 COMMERCE DRIVE SUITE 500-118 |
| Manufacturer City | OAK BROOK IL 60523 |
| Manufacturer Country | US |
| Manufacturer Postal | 60523 |
| Manufacturer Phone | 8778606686 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NOVO SURGICAL MCIVOR MOUTH GAG |
| Generic Name | MCIVOR MOUTH GAG |
| Product Code | KBN |
| Date Received | 2019-04-03 |
| Returned To Mfg | 2019-03-21 |
| Model Number | 4553-20 |
| Catalog Number | 4553-20 |
| Lot Number | M4/17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVO SURGICAL INC. |
| Manufacturer Address | 700 COMMERCE DRIVE SUITE 500-118 OAK BROOK IL 60523 US 60523 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-03 |