MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-11 for DR?GERSORB 800 PLUS (5L) MX00001 manufactured by Dr?gerwerk Ag & Co. Kgaa.
[182909770]
The investigation is still on-going. The results will be provided within a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[182909771]
It was reported that during a case the fraction of expired co2 increased so that replacement of the lime in the bin was necessary. The nurse reportedly was not able to open the new bin. While trying she hurt her right hand and right arm. After the event we were informed that the nurse suffered from searing pain in the thumb and right arm. Additionally it resulted in permanent musculo-tendon pain, an inability to perform some gestures involving hand, wrist and right forearm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611500-2020-00070 |
| MDR Report Key | 9817334 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-03-11 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer G1 | DR |
| Manufacturer Street | MOISLINGER ALLEE 53-55 |
| Manufacturer City | L 23542 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 23542 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DR?GERSORB 800 PLUS (5L) |
| Generic Name | ABSORBENT, CARBON-DIOXIDE |
| Product Code | CBL |
| Date Received | 2020-03-11 |
| Model Number | NA |
| Catalog Number | MX00001 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DR?GERWERK AG & CO. KGAA |
| Manufacturer Address | MOISLINGER ALLEE 53-55 L?BECK 23542 GM 23542 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-11 |