MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2008-02-08 for DB DIAGNOSTICS, TRIPATH 02500-SC manufactured by Coopersurgical, Inc..
[21320899]
The spatula included with the collection kit is scored to facilitate the removal of the head of the spatula. The spatula lots making up the lot of collection kits are no longer in stock. The subject device is not available for evaluation. There is no history of complaints of this nature associated with this product.
Patient Sequence No: 1, Text Type: N, H10
[21588842]
A nurse at a physician's office experienced difficulty while removing the head of the spatula. Some of the sample splashed in to the nurse's eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2008-00003 |
| MDR Report Key | 997671 |
| Report Source | 99 |
| Date Received | 2008-02-08 |
| Date of Report | 2008-02-08 |
| Date of Event | 2007-11-15 |
| Date Mfgr Received | 2008-01-18 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2008-10-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS WILLIAMS |
| Manufacturer Street | 95 CORPORATE DR. |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DB DIAGNOSTICS, TRIPATH |
| Generic Name | COLLECTION KIT |
| Product Code | HHT |
| Date Received | 2008-02-08 |
| Model Number | 02500-SC |
| Lot Number | 57148 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 995516 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | TRUMBULL CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-02-08 |