MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2010-05-28 for HEMOLOK REMOVER XL/L ENDO 544130 manufactured by Teleflex Medical.
[1538022]
The event is reported as: the complaint was forwarded through vendor repair to the mfr on (b)(6) 2010. Further info revealed the device was being used during a demonstration when the handle broke. Not used on a pt. No pt injury.
Patient Sequence No: 1, Text Type: D, B5
[8630602]
No sample will be returned for investigation. Eval: conclusion - the repair facility unable to diagnose root cause. Defective sample was discarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2010-00058 |
| MDR Report Key | 1713807 |
| Report Source | 01,06,07 |
| Date Received | 2010-05-28 |
| Date of Report | 2010-05-06 |
| Date Mfgr Received | 2010-05-06 |
| Date Added to Maude | 2010-10-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANGELA BROWN, MGR |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334901 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 2917 WECK DR. |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOLOK REMOVER XL/L ENDO |
| Generic Name | CLIP REMOVER |
| Product Code | HBQ |
| Date Received | 2010-05-28 |
| Model Number | NA |
| Catalog Number | 544130 |
| Lot Number | 1691221-042 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RTP NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-28 |