MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-31 for ROTATING OSTRUM PUNCH PED 360DG 1.5MMCUP RH551-181 manufactured by Carefusion, Inc.
[125922983]
(b)(4). Bd awareness date provided. Carefusion provided as manufacturer in place of avalign (b)(4) specialty instruments. (b)(4) is the supplier for this instrument. Address: (b)(4). Same information, site contact would be (b)(6). If further information becomes available a follow up medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[125922984]
Customer stated that during a sinus surgery the doctor was opening the right anterior portion of the maxillary sinus and the instrument snapped causing a superficial laceration on the later wall of the nose. The instrument was removed from the sterile field and taken to the decontamination room. There was patient involvement but the patient was fine and there was no delay to the procedure or medical intervention required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-01589 |
| MDR Report Key | 8024512 |
| Date Received | 2018-10-31 |
| Date of Report | 2019-01-04 |
| Date of Event | 2018-10-16 |
| Date Mfgr Received | 2018-10-16 |
| Date Added to Maude | 2018-10-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ROTATING OSTRUM PUNCH PED 360DG 1.5MMCUP |
| Generic Name | EAR, NOSE, AND THROAT MANUAL SURGICAL INSTRUMENT |
| Product Code | KAD |
| Date Received | 2018-10-31 |
| Catalog Number | RH551-181 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 N. FAIRVIEW DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-31 |