MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-10-10 for SEQUENTIAL H400 STERILIZATION WRAP, 48IN. X 48IN. (121CM X 121CM) 68248 991068248 manufactured by O&m Halyard, Inc..
[123841018]
The product involved in the report has been returned and is being processed for evaluation. A review of the device history record is not possible as no lot number was provided. All information reasonably known as of 10-oct-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, inc. , 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, inc. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[123841019]
It was reported that there were two holes on the middle and the edge of the wrap. After surgery, the customer noticed this issue. The customer stated that they are not sure if the holes were opened before use or after use. Additional information was received 18-sept-2018 that states, an email was received, hole was noticed post sterilization. Additional information was received 19-sept-2018 that states, the customer found holes after surgery. However, they were not sure if the hole opened up before sterilization. There was no patient injury. Additional information was received 25-sept-2018 that states there were no problem with the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1054380-2018-00004 |
| MDR Report Key | 7950970 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-10-10 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-09-11 |
| Date Mfgr Received | 2018-10-25 |
| Date Added to Maude | 2018-10-10 |
| 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 3RD FLOOR WEST |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485135 |
| 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 | SEQUENTIAL H400 STERILIZATION WRAP, 48IN. X 48IN. (121CM X 121CM) |
| Generic Name | STERILIZATION PRODUCTS |
| Product Code | FRG |
| Date Received | 2018-10-10 |
| Returned To Mfg | 2018-09-18 |
| Model Number | 68248 |
| Catalog Number | 991068248 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-10-10 |