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 2018-09-21 for QUICK CHECK* H400 STERILIZATION WRAP, 48IN. X 48IN. (121CM X 121CM) 34145 991034145 manufactured by O&m Halyard Inc..
[121014733]
The sample is reported to be available, but has not yet been received by the manufacturer. A review of the device history record is not possible as no lot number was provided. All information reasonably known as of (b)(6) 2018 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 o&m halyard 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 o&m halyard. O&m halyard,inc. 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 o&m halyard complaint database and identified as complaint (b)(4). This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc. , product is defective or caused serious injury.
Patient Sequence No: 1, Text Type: N, H10
[121014734]
It was reported that there were holes fond on the white side of the sterilization wrap. The holes were detected after use. Additional information was reported on (b)(6) 2018 that sttes, "the objects which wrapped with the product in question and sterilized wre used to the patient but no patient injury reported".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1054380-2018-00003 |
| MDR Report Key | 7897689 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-21 |
| Date of Report | 2018-10-12 |
| Date of Event | 2018-08-22 |
| Date Mfgr Received | 2018-08-23 |
| Date Added to Maude | 2018-09-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 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 CAROLYN WAITS |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485136 |
| Manufacturer G1 | HALYARD NORTH CAROLINA, LLC. |
| 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 | QUICK CHECK* H400 STERILIZATION WRAP, 48IN. X 48IN. (121CM X 121CM) |
| Generic Name | STERILIZATION PRODUCTS |
| Product Code | FRG |
| Date Received | 2018-09-21 |
| Model Number | 34145 |
| Catalog Number | 991034145 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | O&M HALYARD INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-21 |