MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-24 for MAYFIELD HEAD HOLDER XXX-HEADREST manufactured by Integra Lifesciences Corporation Oh/usa.
[52950165]
Sus voluntary report# mw5062559 was received from fda on 10aug2016 with the following information: on (b)(6) 2016, a mayfield head holder slipped and lacerated the patient's scalp. Laceration was approximately 2. 5 - 3. 0 inches behind the patient's right ear. No further information could provided.
Patient Sequence No: 1, Text Type: D, B5
[58156961]
Integra has completed their internal investigation on 09/19/2016. The investigation included: results: a dhr review cannot be performed at this time as the lot number, product id nor was the product sent in for inspection. This review will take place once either or has been provided. No manufacturing or design related trend has been identified. Conclusion: in summary: the reporter / this customer has elected not to provide additional information on this incident such as product id, lot code as well as the reporting facility once more details are provided this investigation will be revisited or reopened.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2016-00228 |
| MDR Report Key | 5901530 |
| Date Received | 2016-08-24 |
| Date of Report | 2016-08-10 |
| Date Mfgr Received | 2016-09-19 |
| Date Added to Maude | 2016-08-24 |
| 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 | USER ROWENA BUNUAN |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Street | 4900 CHARLEMAR DRIVE |
| Manufacturer City | CINCINNATI OH 45227 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAYFIELD HEAD HOLDER |
| Generic Name | SKULLCLAMPS AND HEADREST SYSTEMS |
| Product Code | HBM |
| Date Received | 2016-08-24 |
| Catalog Number | XXX-HEADREST |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Address | 4900 CHARLEMAR DRIVE 4900 CHARLEMAR DRIVE CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-24 |