MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2014-04-09 for SENSI-CARE STING FREE ADHESIVE RELEASER/REMOV 413499 manufactured by Convatec Limited.
[4553218]
It is reported that after second use the skin began to sting and redness occurred. It is also reported that following the removal of the wafer, end-user chose not to use the product and the redness is now gone.
Patient Sequence No: 1, Text Type: D, B5
[11769172]
Based on the available info, this event is deemed to be a serious injury. It is reported that end-user never had skin breakdown or blistering, and product has been discontinued from use. Final quality evaluation performed on (b)(4) 2014, and an investigation conducted by third party supplier on (b)(6) 2014 based on the review of retained samples and quality records. Results from the review were found to meet specification. No sample has been provided for further investigation. No other complaints have been received for irritation issues. The chemicals in this product are inert and are used frequently in skin care products, the supplier believes this to be an isolated incident. No further action required as per convatec's governing complaint handling procedure. Reported to the fda on 04/08/2014. Convatec will continue to track and monitor such complaints according to convatec inc. 's complaint handling and capa procedures. Please note: this report replaces initial report submitted on 10/02/2013 under patient identifier # 286172 and mfr. Report # 1049092-2013-00068.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000317571-2014-00019 |
| MDR Report Key | 3763465 |
| Report Source | 04,07 |
| Date Received | 2014-04-09 |
| Date of Report | 2013-09-03 |
| Date of Event | 2013-08-22 |
| Date Mfgr Received | 2013-09-03 |
| Date Added to Maude | 2014-04-24 |
| 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 | MATTHEW WALENCIAK, INTERIM ASSOC. |
| Manufacturer Street | 200 HEADQUARTERS PARK DR MEDICAL SAFETY & COMPLIANCE |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9083779293 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 1049092-2013-00068. |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSI-CARE STING FREE ADHESIVE RELEASER/REMOV |
| Generic Name | SOLVENT, ADHESIVE TAPE |
| Product Code | KOX |
| Date Received | 2014-04-09 |
| Model Number | 413499 |
| Catalog Number | 413499 |
| Lot Number | 131812017-03 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC LIMITED |
| Manufacturer Address | FIRST AVENUE DEESIDE INDUSTRIAL PARK DEESIDE, FLINTSHIRE CH 52NU UK CH 5 2NU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-04-09 |