MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-17 for PILLING IPN004223 200100 manufactured by Teleflex Medical.
[117466641]
Package was opened for spine procedure. Upon counting, package had 11 sponges instead of the usual 10. Pack was removed from sterile field and isolated per policy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7792936 |
| MDR Report Key | 7792936 |
| Date Received | 2018-08-17 |
| Date of Report | 2018-07-31 |
| Date of Event | 2018-06-14 |
| Report Date | 2018-07-31 |
| Date Reported to FDA | 2018-07-31 |
| Date Reported to Mfgr | 2018-08-17 |
| Date Added to Maude | 2018-08-17 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| 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 | 3 |
| Brand Name | PILLING |
| Generic Name | GAUZE/SPONGE, INTERNAL |
| Product Code | EFQ |
| Date Received | 2018-08-17 |
| Model Number | IPN004223 |
| Catalog Number | 200100 |
| Lot Number | 17E1758 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | 3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-17 |