MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-13 for PACEMAKER PACK manufactured by Avid Medical.
[73022601]
The cath lab found long black hair in different cath trays supplied by avid. The hair was found in both a cardiac cath pack and a pacemaker pack. The packs were not used. Cardiac cath pack catalog #: vmcl025-4 lot # 1221276. Pacemaker pack catalog # vmcl027-02 lot #: 1223857.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069118 |
| MDR Report Key | 6497119 |
| Date Received | 2017-04-13 |
| Date of Report | 2017-04-13 |
| Date of Event | 2017-04-05 |
| Date Added to Maude | 2017-04-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PACEMAKER PACK |
| Generic Name | PACEMAKER PACK |
| Product Code | DTB |
| Date Received | 2017-04-13 |
| Returned To Mfg | 2017-04-07 |
| Lot Number | 1223857 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVID MEDICAL |
| Manufacturer Address | TOANA VA 23168 US 23168 |
| Brand Name | AVID CARDIAC CATH PACK |
| Generic Name | AVID CARDIAC CATH PACK |
| Product Code | OES |
| Date Received | 2017-04-13 |
| Returned To Mfg | 2017-04-07 |
| Lot Number | 1221276 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | AVID MEDICAL |
| Manufacturer Address | TOANA VA 23168 US 23168 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-13 |