MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-21 for ANCHORFAST ORAL ENDOTRACH TUBE FASTENER 9799 manufactured by Hollister Incorporated.
[176942736]
No sample received and no lot number provided. Photo provided shows patient with full lips. The ifu states to use caution in patients with full lips. Without the sample or lot number hollister is unable to perform a full investigation regarding the report upper lip injury. Trend analysis conducted for the reported issue and no adverse trend observed. This will continue to be monitored in hollister's post marketed complaint system and actions will be taken if/when indicated. Patient's age and weight was not provided so estimates were used.
Patient Sequence No: 1, Text Type: N, H10
[176942737]
It was reported that an anchor fast oral endotracheal tube fastener was in place on a patient for a total of 3 days. When the device was discontinued, a mucous membrane pressure injury was observed inside the upper lip and gums. The patient required plastic surgery and lost his two upper front teeth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119193-2020-00002 |
| MDR Report Key | 9612504 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-21 |
| Date of Event | 2019-09-20 |
| Date Mfgr Received | 2019-12-04 |
| Date Added to Maude | 2020-01-21 |
| 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. 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 | 2020-01-21 |
| Catalog Number | 9799 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2020-01-21 |