MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04,05,06 report with the FDA on 2007-01-19 for TIDI SALIVA EJECTOR 9307 manufactured by Tidi Products, Llc.
[754495]
Customr reported that blue tip of saliva ejector came off while suctioning pt. Tip was removed from patient's oral cavity without incident.
Patient Sequence No: 1, Text Type: D, B5
[8040835]
Customer provided to company additional and corrected info, stating that tip of saliva ejector came off while nurse was suctioning pt during post-operative, post-anesthesia recovery likely involving intubation. Customer further stated that report incorrectly identified outcome attributable to event as "disability or permanent damage"; there was no disability or damage as tip was removed without incident. Company communicated with customer by phone and e-mail several times to discuss and investigate the event. At company's request, customer is attempting to gather further info about customer's inventory of product (e. G. , batch or lot info), distributor info, and further detail on reported event. Company placed quality hold on all product in inventory to conduct internal inspection of product in stock. Product label states: "warning! A loose tip can create a choking hazard. Check tip before use. " within 7 days of receipt of report, company notified mfg site of report. Mfg site provided its quality systems certificates for iso 13485:2003, iso 9001:2000, for compliance. To continue investigation, company will provide mfg site with lot and batch number of product at issue when it is received from customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182318-2007-00001 |
| MDR Report Key | 975273 |
| Report Source | 00,04,05,06 |
| Date Received | 2007-01-19 |
| Date of Report | 2007-01-19 |
| Date of Event | 2006-10-26 |
| Date Mfgr Received | 2006-12-21 |
| Date Added to Maude | 2008-01-08 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MELANIE ZIEMER |
| Manufacturer Street | 570 ENTERPRISE DR PO BOX 806 |
| Manufacturer City | NEENAH WI 549570806 |
| Manufacturer Country | US |
| Manufacturer Postal | 549570806 |
| Manufacturer Phone | 9207514380 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TIDI SALIVA EJECTOR |
| Generic Name | MOUTHPIECE, SALIVA EJECTOR |
| Product Code | DYN |
| Date Received | 2007-01-19 |
| Model Number | 9307 |
| Catalog Number | 9307 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 943317 |
| Manufacturer | TIDI PRODUCTS, LLC |
| Manufacturer Address | * NEENAH WI * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-01-19 |