MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2013-11-26 for ADHESIVE REMOVER WIPE 037443 manufactured by Convatec Inc..
[3994615]
It is reported that after a few minutes of using the product, the end-user's skin presented with redness and itching everywhere product was applied.
Patient Sequence No: 1, Text Type: D, B5
[11319855]
Based on the available info, this event is deemed a serious injury. It is reported that end-user discontinued use of product. In addition, end-user applied skin prop, and thoroughly washed skin which resolved itching as a result. No additional patient/event details have been provided to date. A return sample for evaluation is not expected. Should additional info becomes available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243969-2013-00253 |
| MDR Report Key | 3514299 |
| Report Source | 04,07 |
| Date Received | 2013-11-26 |
| Date of Report | 2013-10-31 |
| Date of Event | 2013-10-30 |
| Date Mfgr Received | 2013-10-30 |
| Date Added to Maude | 2013-12-12 |
| 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, ASSOC. 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 | ADHESIVE REMOVER WIPE |
| Generic Name | SOLVENT, ADHESIVE TAPE |
| Product Code | KOX |
| Date Received | 2013-11-26 |
| Model Number | 037443 |
| Catalog Number | 037443 |
| Lot Number | UNK |
| 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 INC. |
| Manufacturer Address | 200 HEADQUARTERS PARK DR. SKILLMAN NJ 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-26 |