MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-12-21 for AGS manufactured by Getinge Disinfection Ab.
[131138049]
(b)(4). The issue is being investigated by manufacturing site.
Patient Sequence No: 1, Text Type: N, H10
[131138050]
On (b)(4) 2018 getinge disinfection (b)(4) became aware of an incident with one of devices- ags. As stated by customer, the arm that pushes basket on loading side got stuck and required manual intervention. It caused an injury of an employee whose arm was caught under the cart. After the incident, the employee went into er for treatment purpose. Ags is a supplemental product to the washer disinfector registered as the medical device and we decided to report incident resulted in serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616931-2018-00011 |
| MDR Report Key | 8189031 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-21 |
| Date of Report | 2019-02-11 |
| Date of Event | 2018-12-05 |
| Date Facility Aware | 2018-12-17 |
| Report Date | 2018-12-21 |
| Date Reported to FDA | 2018-12-21 |
| Date Mfgr Received | 2018-12-17 |
| Device Manufacturer Date | 2006-12-15 |
| Date Added to Maude | 2018-12-21 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR DENNIS GENITO |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097515 |
| Manufacturer G1 | GETINGE DISINFECTION AB |
| Manufacturer Street | LJUNGADALSGATAN 11 VAXJO KRONOBERGS IAN [SE-07] |
| Manufacturer City | VAXJO, 35115 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 35115 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AGS |
| Generic Name | AGS |
| Product Code | PEC |
| Date Received | 2018-12-21 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GETINGE DISINFECTION AB |
| Manufacturer Address | LJUNGADALSGATAN 11 VAXJO KRONOBERGS IAN [SE-07] VAXJO, 35115 SW 35115 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-21 |