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 |