MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-05-21 for UNIVERSAL REMOVER WIPES 7300 manufactured by Hollister Incorporated.
[145678079]
User does not know the lot number and does not have the wipes so dhr review and sample evaluation is not possible. Trend data reviewed and no other report of a fire could be found. The box and packets of wipes both have the highly flammable words and symbol on it. The ifu specifically states: flammable: no smoking. Do not use near flame or any incandescent material, electrical appliance or source of heat. Keep away from sources of ignition. End user's weight is not known so an estimation was used in this medwatch. The exact electronic cutter device is not known.
Patient Sequence No: 1, Text Type: N, H10
[145678080]
It was reported that a universal remover wipe had been used to remove tape from a patient's neck. The doctor then used an electronic cutter device somewhere which led to a fire. The fire burned the patient's face. No information is available about the extent of the burn or treatment provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1480288-2019-00001 |
| MDR Report Key | 8628904 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-05-21 |
| Date of Report | 2019-05-21 |
| Date of Event | 2019-04-26 |
| Date Mfgr Received | 2019-05-11 |
| Date Added to Maude | 2019-05-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LINDA WISOWATY |
| Manufacturer Street | 2000 HOLLISTER DRIVE |
| Manufacturer City | LIBERTYVILLE. IL 600483781 |
| Manufacturer Country | US |
| Manufacturer Postal | 600483781 |
| Manufacturer Phone | 8476802170 |
| Manufacturer G1 | ACUPAC PACKAGING INC |
| Manufacturer Street | 55 RAMAPO VALLEY RD |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL REMOVER WIPES |
| Generic Name | UNIVERSAL REMOVER WIPES |
| Product Code | KOX |
| Date Received | 2019-05-21 |
| Catalog Number | 7300 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER INCORPORATED |
| Manufacturer Address | 2000 HOLLISTER DRIVE LIBERTYVILLE. 600483781 US 600483781 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-21 |