MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for MCIVOR FRAME ONLY 450141 manufactured by Integra York, Pa Inc..
[143572182]
The device was returned to the manufacturer for analysis. There was one mcivor mouth gag, frame only returned used/processed with the complaint that a screw fell out of the frame. The product specification was reviewed and there is no screws missing from the returned instrument. No lot number was provided to perform device history record review. The complaint is unconfirmed/testing within specification. Device identifier: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[143572183]
A sales representative reported in behalf of the customer that the screw of 450-141 mcivor frame fell off into the back of the patient? S throat during an unspecified procedure. The surgeon was able to retrieve it. The date of the event was not known. There was no patient injury reported. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2019-00057 |
| MDR Report Key | 8549116 |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-05 |
| Date Mfgr Received | 2019-04-05 |
| Date Added to Maude | 2019-04-25 |
| 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 | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MCIVOR FRAME ONLY |
| Generic Name | N/A |
| Product Code | KBN |
| Date Received | 2019-04-25 |
| Returned To Mfg | 2019-04-19 |
| Catalog Number | 450141 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-25 |