MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-06-25 for ANCHORFAST ORAL ENDOTRACH TUBE FASTENER 9799 manufactured by Hollister Incorporated.
[149136005]
Patient's age, gender, weight and date of event not provided so estimations were used in this report. Event details were not available from the account due to this event taking place "a while ago". The lot number, photos, event details and actual device were not provided so a thorough investigation could not be conducted. A review of post market surveillance data relating to this reported issue was carried out and no trends were observed. It is not known if this was a device problem or use error. Hollister was unable to determine a root cause of the reported foam bumper separation.
Patient Sequence No: 1, Text Type: N, H10
[149136006]
It was reported that there were a couple of patients where the lip foam bumper separated from the anchor fast device and could not be located. In addition the patient had a lip pressure but not deep tissue injury. This happened a while ago and no event information is available. This is for the first of the two patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119193-2019-00026 |
| MDR Report Key | 8731500 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-06-25 |
| Date of Report | 2019-06-25 |
| Date of Event | 2019-05-11 |
| Date Mfgr Received | 2019-06-11 |
| Date Added to Maude | 2019-06-25 |
| 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. LINDA WISOWATY |
| Manufacturer Street | 2000 HOLLISTER DRIVE |
| Manufacturer City | LIBERTYVILLE. IL 600483781 |
| Manufacturer Country | US |
| Manufacturer Postal | 600483781 |
| Manufacturer Phone | 8476802170 |
| Manufacturer G1 | HOLLISTER INCORPORATED |
| Manufacturer Street | 366 DRAFT AVENUE |
| Manufacturer City | STUARTS DRAFT VA 244779998 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 244779998 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANCHORFAST ORAL ENDOTRACH TUBE FASTENER |
| Generic Name | ANCHORFAST ORAL ENDOTRACH TUBE FASTENER |
| Product Code | CBH |
| Date Received | 2019-06-25 |
| Catalog Number | 9799 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-06-25 |