MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-11-01 for COPAN VENTURI TRANSYSTEM 108CF.FR manufactured by Copan Italia S.p.a..
[3001007]
The event happened in (b)(6). "we have a reported incident where the cotton bud became detached from the shaft of a swab (108 cf. Fr), while a doctor was swabbing the throat of a (b)(6) child. It was recovered satisfactorily, but there was some pt distress understandably. No abnormality was noted with the swab prior to use. The swab was in the child's mouth for "half a second.
Patient Sequence No: 1, Text Type: D, B5
[10294521]
Manufacturer investigation report: our original complaint investigation could not confirm any malfunction or defect in the device lot associated with this incident. The dhr was reviewed and no anomalies have been found during all the production steps of the different product components. The test performed on the retained sample from the claimed lot was done following internal sop for mechanical resistance test. All the tested swabs gave results within the acceptability limits. (note: the samples tested were coming from the same large lot number but not the same batch number). As results of fda inspection, copan (b)(4) has reviewed it's criteria for a reportable event and has reviewed complaints from 2011 and 2012 to identify reportable events under the revised reporting criteria.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002444944-2012-00001 |
| MDR Report Key | 2845140 |
| Report Source | 08 |
| Date Received | 2012-11-01 |
| Date of Report | 2011-09-06 |
| Date of Event | 2011-01-01 |
| Date Mfgr Received | 2011-09-06 |
| Device Manufacturer Date | 2010-01-01 |
| Date Added to Maude | 2012-12-11 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | VIA F. PEROTTI, 10 |
| Manufacturer City | BRESCIA 25125 |
| Manufacturer Country | IT |
| Manufacturer Postal | 25125 |
| Manufacturer Phone | 302687212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COPAN VENTURI TRANSYSTEM |
| Product Code | JSL |
| Date Received | 2012-11-01 |
| Model Number | 108CF.FR |
| Catalog Number | 108CF.FR |
| Lot Number | TUSA00 |
| ID Number | 001A02 |
| Device Expiration Date | 2011-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COPAN ITALIA S.P.A. |
| Manufacturer Address | VIA PEROTTI, 10 BRESCIA 25125 IT 25125 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-11-01 |