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 2018-05-30 for QUICK CHECK* H600 STERILIZATION WRAP, 45IN. X 45IN. (114CM X 114CM) 34164 991034164 manufactured by Halyard Health.
[109634482]
The product involved in the report has been returned and is being processed for evaluation. A review of the device history record is in-progress. Upon completion of the sample evaluation and investigation; a follow-up report will be filed. All information reasonably known as of 30may2018 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
[109634483]
It was reported by the customer that a hole was discovered in a sterilization wrap post or use. Additional information was received (b)(6) 2018 from customer that states, "there was no patient harm and the hole was seen before patient care started. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1054380-2018-00002 |
| MDR Report Key | 7553837 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-30 |
| Date of Report | 2018-06-27 |
| Date of Event | 2018-05-04 |
| Date Mfgr Received | 2018-06-27 |
| Device Manufacturer Date | 2017-11-03 |
| Date Added to Maude | 2018-05-30 |
| 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 | 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 NORTH CAROLINA, INC. |
| Manufacturer Street | 1300 ORCHARD HILL 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 | QUICK CHECK* H600 STERILIZATION WRAP, 45IN. X 45IN. (114CM X 114CM) |
| Generic Name | STERILIZATION PRODUCTS |
| Product Code | FRG |
| Date Received | 2018-05-30 |
| Returned To Mfg | 2018-05-23 |
| Model Number | 34164 |
| Catalog Number | 991034164 |
| Lot Number | LT7307 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-30 |