MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-06-20 for CONMED SCOPE SAVER BITE BLOCK 000429 manufactured by Conmed Corporation.
[10086239]
The suspect device in this reported incident is the conmed scope saver bite block compromised of a polyethylene material with an attachable latex-free strap. This is a single-use, disposable, nonsterile device indicated to aid in the passage of an endoscope and to protect an endoscope as it is passed through a patient's mouth during an upper endoscopic procedure. A dhr/lhr, device history record/lot history record, review was not possible as the lot number for this product has not been made available. No laboratory examination was performed on the complaint product, as no device was made available for examination or confirmation of defect or confirmation of conmed product. A twenty-four (24) month review of complaint history shows this as an isolated incident and there have not been any other reports of any skin reaction to the latex-free strap. There may be a multiple of possible causes either manufacturing or user related. In process inspection and visual checks during manufacture were accomplished to ensure proper production of the devices. The bite block strap meets the biocompatibility requirements of iso 10993, and, the bite block strap is produced from latex-free materials. Possible cause could be allergic reaction during the operating procedure to either the strap of the suspect device, or, allergic reaction to the cannula from another manufacturer that apparently was in the same vicinity of skin contact as the reported suspect device. No root causes can be confirmed without examination of the product. The complaint can be neither confirmed nor unconfirmed at this time. As this is an isolated incident, and, the complaint investigation has not identified any manufacturing defects with this complaint, no corrective action is recommended at this time. The physician had requested information regarding the materials the device is made of and this was sent to the care provider. Conmed is considering this complaint closed. Device never returned to conmed corp.
Patient Sequence No: 1, Text Type: N, H10
[17133444]
It was reported, "patient experienced a reaction after an egd (esophagogastroduodenoscopy). Hospital believes it was either from the bite block strap or a cannula from another company that was used. The patient's lips and nose swelled and they had a rash on their cheeks when they were home later that night. Reporter says it was probably treated but she doesn't know for sure or with what. Doctor wanted to know what materials bite block is made of. " it is unknown if the skin reaction was medically treated in any way. Due to this unknown factor the incident is being reported to the fda.
Patient Sequence No: 1, Text Type: D, B5
[17473855]
The device is not being returned to conmed corporation for evaluation. Photographs have not been taken of the device or of the skin irritation. At the completion of the quality engineering investigation of this reported incident, a supplemental report will be filed. Device discarded by end-user.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007305485-2012-00040 |
| MDR Report Key | 2622692 |
| Report Source | 05,06 |
| Date Received | 2012-06-20 |
| Date of Report | 2012-08-07 |
| Date of Event | 2012-06-07 |
| Date Mfgr Received | 2012-06-08 |
| Date Added to Maude | 2012-06-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. STEPHEN CASANOVA |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal | 135025994 |
| Manufacturer Phone | 3156243463 |
| Manufacturer G1 | CONSOLIDATED MEDICAL EQUIPMENT COMPANY |
| Manufacturer Street | AVE. ALEJANDRO DUMAS NO. 11321 COMPLEJO INDUSTRIAL CHIHUAHUA |
| Manufacturer City | CHIHUAHUA, CHIHUAHUA CP 1136 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | CP 1136 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONMED SCOPE SAVER BITE BLOCK |
| Generic Name | BITE BLOCK |
| Product Code | MNK |
| Date Received | 2012-06-20 |
| Catalog Number | 000429 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 13502599 US 13502 5994 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-06-20 |