MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-12 for ULTRA-COAT KERRISON SPURLING 40D UP 9 2MM RB5972 manufactured by Integra York, Pa Inc..
[138795991]
The product was returned for evaluation. There was one ultra-coat kerrison returned used/processed showing wear. The tests/measurement used is the visual/card stock method. There was no sticking observed, and the product cut the card stock a tip-mid cut-full cut. The complaint is unconfirmed. The product tested within specifications. Device identifier: (b)(4). Linked to mfr report number: 2523190-2019-00038.
Patient Sequence No: 1, Text Type: N, H10
[138795992]
1 of 2 reports. A customer reported that on (b)(6) 2019, the rb5972b, ultra-coat kerrison spurling 40d up 9 2mm was? Sticking bad? During a neuro procedure. A 30-minute delay due to the product problem was reported, however there was no patient adverse consequence/or injury reported. The action that was taken after the product problem occurred was that a different size was given to the doctor from the same set. No other clinical information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2019-00037 |
| MDR Report Key | 8411670 |
| Date Received | 2019-03-12 |
| Date of Report | 2019-02-18 |
| Date of Event | 2019-02-18 |
| Date Mfgr Received | 2019-02-18 |
| Date Added to Maude | 2019-03-12 |
| 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 | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ULTRA-COAT KERRISON SPURLING 40D UP 9 2MM |
| Generic Name | ULTRA-COAT |
| Product Code | HAE |
| Date Received | 2019-03-12 |
| Returned To Mfg | 2019-02-25 |
| Catalog Number | RB5972 |
| Lot Number | 081015A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-12 |