MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,08 report with the FDA on 2015-02-17 for SHUR-CLENS WOUND CLEANSER 121222 manufactured by Convatec, Inc.
[5514681]
It was reported that the product container had yellow particles and was described as glue particles near the top closure. This issue was noticed prior to use.
Patient Sequence No: 1, Text Type: D, B5
[12810602]
Based on the available info, this event is deemed to be a reportable malfunction. No additional patient/event details have been provided to date. Should additional info become available a f/u report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[39251751]
Additional information was received on june 26, 2015. Third party manufacturer performed a review of 33 returned samples and observed a yellow precipitate dried on the outside of the vials. Efforts were made to reproduce the precipitate but those efforts failed. Ftir testing also failed to identify the substance. After a through review of the returned product along with a batch record review a discrepancy was identified. An unidentified yellow particulate was discovered on the outside of the returned ampoules. Corrective action/ preventive action was implemented in order to make improvement sin the aql procedure. This warranted further action and non-conformance was executed to further address the issue. No additional patient/event details have been provided to date. Should additional information become available a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1049092-2015-00105 |
MDR Report Key | 4534530 |
Report Source | 00,08 |
Date Received | 2015-02-17 |
Date of Report | 2015-01-30 |
Date Mfgr Received | 2015-01-30 |
Device Manufacturer Date | 2014-08-01 |
Date Added to Maude | 2015-03-23 |
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 | 3 |
Event Location | 3 |
Manufacturer Contact | MATTHEW WALENCIAK, INTERIM DIR |
Manufacturer Street | 211 AMERICAN AVE. |
Manufacturer City | GREENSBORO NC 27409 |
Manufacturer Country | US |
Manufacturer Postal | 27409 |
Manufacturer Phone | 9083779293 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SHUR-CLENS WOUND CLEANSER |
Generic Name | COSMETIC |
Product Code | KOY |
Date Received | 2015-02-17 |
Model Number | 121222 |
Lot Number | A14BTO |
Device Expiration Date | 2019-08-10 |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | CONVATEC, INC |
Manufacturer Address | 211 AMERICAN AVE. GREENSBORO NC 27409 US 27409 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2015-02-17 |