MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-03-30 for AMPLATZ TYPE RENAL DILATOR M0062601000 260-100 manufactured by Boston Scientific Corporation.
[1112950]
It was reported to boston scientific corp that an amplatz renal dilator was received in materials management at the user facility. During unpacking the device, they noticed a hole in the packaging. Follow up confirmed that the hole was in the sterile packaging. The device was not used on a patient, and there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[8268111]
The device has been received, but an evaluation has not yet been performed. Therefore, a failure analysis is not available and we have not yet determined the relationship between this device and the cause for this failure. If there is any further relevant information, a supplemental manufacturer's report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2009-01441 |
| MDR Report Key | 1424317 |
| Report Source | 06 |
| Date Received | 2009-03-30 |
| Date of Report | 2009-03-02 |
| Date of Event | 2009-02-25 |
| Date Mfgr Received | 2009-03-02 |
| Device Manufacturer Date | 2008-10-01 |
| Date Added to Maude | 2009-08-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLES MONTGOMERY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836132 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 780 BROOKSIDE DR |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLATZ TYPE RENAL DILATOR |
| Product Code | GCC |
| Date Received | 2009-03-30 |
| Returned To Mfg | 2009-03-12 |
| Model Number | M0062601000 |
| Catalog Number | 260-100 |
| Lot Number | 12143529 |
| Device Expiration Date | 2012-10-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | SPENCER IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-30 |