MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2009-04-27 for AMPLATZ TYPE RENAL DILATOR M0062601000 260-100 manufactured by Boston Scientific Corporation.
[1103477]
It was reported to boston scientific corp that a renal dilator was inspected upon receipt at the user facility. According to the complainant, during unpacking, the internal "slots" that the device is packed in were damaged. There was no damage to the outer packaging and it is unk if the device was damaged. There was no pt involvement in this event.
Patient Sequence No: 1, Text Type: D, B5
[8270299]
The device has been received, but a failure analysis has not yet been completed. Upon completion of the failure analysis, if there is any further relevant info from that review, a supplemental mdr will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2009-02066 |
| MDR Report Key | 1421917 |
| Report Source | 06,07 |
| Date Received | 2009-04-27 |
| Date of Report | 2009-03-31 |
| Date of Event | 2009-03-31 |
| Date Mfgr Received | 2009-03-31 |
| Device Manufacturer Date | 2009-02-01 |
| Date Added to Maude | 2009-11-23 |
| 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 | 2009-04-27 |
| Returned To Mfg | 2009-04-13 |
| Model Number | M0062601000 |
| Catalog Number | 260-100 |
| Lot Number | 12409412 |
| Device Expiration Date | 2013-02-17 |
| 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 | 2009-04-27 |