MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-11-30 for STRYKEFLOW2 WITHOUT TIP (6BX) 0250070500 manufactured by Stryker Endoscopy Puerto Rico.
[781934]
It was reported by the customer that when the package was opened 1 out of 6 products in the box was not packaged properly and therefore unsterile and not usable.
Patient Sequence No: 1, Text Type: D, B5
[8034132]
Add'l info will be provided when investigatin is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2648666-2007-00081 |
| MDR Report Key | 956755 |
| Report Source | 04 |
| Date Received | 2007-11-30 |
| Date of Report | 2007-11-01 |
| Date of Event | 2007-11-01 |
| Date Mfgr Received | 2007-11-01 |
| Device Manufacturer Date | 2007-11-15 |
| Date Added to Maude | 2008-03-13 |
| 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 | LUPE GARCIA |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER PUERTO RICO, LTD. |
| Manufacturer Street | HWY. 3, KM. 130.2 LAS PALMAS INDUSTRIAL PK |
| Manufacturer City | ARROYO PR 00615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKEFLOW2 WITHOUT TIP (6BX) |
| Generic Name | TUBING |
| Product Code | EFS |
| Date Received | 2007-11-30 |
| Catalog Number | 0250070500 |
| Lot Number | 07288FG2 |
| Device Expiration Date | 2007-10-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 959528 |
| Manufacturer | STRYKER ENDOSCOPY PUERTO RICO |
| Manufacturer Address | ARROYO PR 00615 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-30 |