MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2013-10-02 for SENSI-CARE ADHESIVE REMOVER RELEASER UNK manufactured by Unk.
[3764153]
End user reported after second use the skin began to sting and redness occurred.
Patient Sequence No: 1, Text Type: D, B5
[11201976]
Based on the available information, this event is deemed a serious injury. From a clinical perspective, a casual relationship between the wafer and this event is deemed possible because product use is temporally associated with the skin where the problem occurred. The end user removed the wafer and reports that now the redness now gone. The end user reported never having skin breakdown or blistering or any reaction to the product use. The actual product code could not be identified by the customer and the territory manager. Therefore, the exact manufacturing site is unknown. 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 | 1049092-2013-00068 |
| MDR Report Key | 3387454 |
| Report Source | 04,07 |
| Date Received | 2013-10-02 |
| Date of Report | 2013-09-03 |
| Date of Event | 2013-08-22 |
| Date Mfgr Received | 2013-09-03 |
| Date Added to Maude | 2013-10-10 |
| 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 | MARY SZARO, ASSOCIATE DIRECTOR |
| Manufacturer Street | 200 HEADQUARTERS PARK DR. |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042450 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSI-CARE ADHESIVE REMOVER RELEASER |
| Generic Name | SOLVENT ADHESIVE TAPE |
| Product Code | KOX |
| Date Received | 2013-10-02 |
| Model Number | UNK |
| Catalog Number | UNK |
| 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 | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-02 |