MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2018-10-19 for WELCH ALLYN, INC 117-70 manufactured by Covidien Ireland Mfg Tullamore.
[124360405]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[124360406]
According to the reporter, during use, the air in the cuff did not come out. It was reported that there was some resistance since injecting air. A customer indicated that there was patient involvement but no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2018-00647 |
| MDR Report Key | 7985245 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2018-10-19 |
| Date of Report | 2018-10-19 |
| Date of Event | 2018-09-26 |
| Date Mfgr Received | 2018-09-26 |
| Date Added to Maude | 2018-10-19 |
| 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 | AVI KLUGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | MMJ SA DE CV(USD) |
| Manufacturer Street | AVE HENEQUEN NO 1181 DESARROL |
| Manufacturer City | CIUDAD JUAREZ,MX 32590 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32590 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WELCH ALLYN, INC |
| Generic Name | OPHTHALMOSCOPE, AC-POWERED |
| Product Code | HLI |
| Date Received | 2018-10-19 |
| Returned To Mfg | 2019-05-14 |
| Model Number | 117-70 |
| Catalog Number | 117-70 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN IRELAND MFG TULLAMORE |
| Manufacturer Address | SRAGH INDUSTRIAL ESTATE,RAHAN TULLAMORE 32590 32590 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-19 |