MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-05-05 for SCHROEDER TENACULUM FCPS 10 505200 manufactured by .
[1206579]
The customer reports that the original product was a pilling # (b)(4). When cross-referenced to use your product, we ordered a (b)(4). Since then, the gyn clinic has had patients returning due to bleeding for cauterization of the puncture sites. The dr looked closely and found that this replacement is not the same as the pilling product. It is more rounded at the tip. Not a correct cross-reference. This device has been in use by the customer since (b)(4) 2008 through (b)(4), 2009.
Patient Sequence No: 1, Text Type: D, B5
[8460382]
The device involved in the reported incident has been received for evaluation. An investigation has been initiated based on the reported information. Integra lifesciences corporation is filling on behalf of the initial distributor j. Jamner surgical instruments. Correspondence should be sent to: integra lifesciences corporation, (b)(4). Attention: corporate complaints coordinator.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2430952-2009-00005 |
| MDR Report Key | 1378567 |
| Report Source | 05 |
| Date Received | 2009-05-05 |
| Date of Report | 2009-05-05 |
| Date Facility Aware | 2009-04-06 |
| Date Added to Maude | 2011-03-30 |
| 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 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCHROEDER TENACULUM FCPS 10 |
| Generic Name | NA |
| Product Code | HDC |
| Date Received | 2009-05-05 |
| Catalog Number | 505200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-05-05 |