MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-04-18 for KIMGUARD ONE-STEP* QUICK CHECK* STERILIZATION WRAP, KC 600, 36IN X 36IN 34151 991034151 manufactured by Halyard Health.
[73021428]
The sample is reportedly available for this complaint but was not returned when this report was filed. A review of the device history record is not possible as a valid julian date was not provided. Root cause could not be determined. All information reasonably known as of 10apr2017 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. The information provided by halyard health represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health. Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the halyard health complaint database and identified as complaint (b)(4). Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[73021429]
It was reported that a patient received a burn from a sterilization wrap in the operating room. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5
[74926605]
(b)(4). All information reasonably known as of 04may2017 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. The information provided by halyard health represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health. Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1054380-2017-00001 |
| MDR Report Key | 6499896 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-04-18 |
| Date of Report | 2017-04-17 |
| Date of Event | 2017-03-30 |
| Date Mfgr Received | 2017-04-17 |
| Date Added to Maude | 2017-04-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | HALYARD LEXINGTON INC. |
| Manufacturer Street | 389 CLYDE FITZGERALD ROAD |
| Manufacturer City | LINWOOD NC 27299 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27299 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KIMGUARD ONE-STEP* QUICK CHECK* STERILIZATION WRAP, KC 600, 36IN X 36IN |
| Generic Name | STERILIZATION WRAP |
| Product Code | FRG |
| Date Received | 2017-04-18 |
| Model Number | 34151 |
| Catalog Number | 991034151 |
| Lot Number | LT5563 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-18 |