MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-12-11 for SURGICAL CLIPPER BLADE(FOR GENERAL USE) 4406 manufactured by Carefusion, Inc.
[129906160]
(b)(4) initial emdr. A follow up will be submitted if additional information is received. A sample was not provided for investigation. Due to lack of sample, the failure mode could not be confirmed. Master production records were reviewed for the lot number and no non-conformances were noted during the manufacturing of this lot. Panasonic? S records indicate that the reviewed batch record passed all the in process inspection. Due to a lack of sample, a possible root cause could not be determined. Bd will continue to track and trend for this reported failure mode.
Patient Sequence No: 1, Text Type: N, H10
[129906161]
Customer contacted associate telephonically; associate requested a written complaint form from them with relevant product information and any photos available. Associate has arranged to pick up the items in question and to do training at the hospital on 22 may 2018. Training sessions have been set up for the relevant staff and an appointment with the dr who complained about the product. (b)(6) lifehealth carefusion clippers complaint: on 22 may i visited dr. (b)(6), the "orthopeadic" surgeon that lodged the initial complaint. He explained to me that he personally shaves his patients in theatre just before surgery. He found that when he clips over bony ridges (such as the prominences on the knees) the clippers tend to scratch the patients skin leaving abrasions. As theatre time is billed by the minute? Estimated r200 per minute it is important to shave as quickly as possible. Thus when speed is added to the shaving the incidents occur. He said that the previous clippers used did not cause these types of incidents. He then proceeded to demonstrate by shaving his own leg and knee and had me shave his leg / knee too. The clippers did cause raised areas on the bony protuberances but did not break the skin (his knee was not very bony). I asked him if he would be willing to try out our other blades for the clippers to see if that could resolve the issue (the sensitive blade) and he agreed that he would be willing to try it. I have requested samples of the blades to be sent to dr. (b)(6) via mr. (b)(6) for him to trial (currently only the general clipper blade is available in the hospital). The blades should be available by tuesday the 29th or wednesday the 30th of may 2018. I have also conducted training in all the wards of the hospital on the carefusion clippers. Copies of training records have been sent to sr. (b)(6) and mr. (b)(6) at (b)(6) hospital as well as the training video link for the carefusion clippers. I queried if the patient needed any medical treatment as a result of the shaving incident and he said the patient had been placed on antibiotics for the operation. Should you have any further queries regarding this issue please do not hesitate to contact me.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-00382 |
| MDR Report Key | 8150582 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-12-11 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-04-25 |
| Date Mfgr Received | 2018-05-03 |
| Date Added to Maude | 2018-12-11 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICAL CLIPPER BLADE(FOR GENERAL USE) |
| Generic Name | RAZOR, SURGICAL |
| Product Code | LWK |
| Date Received | 2018-12-11 |
| Catalog Number | 4406 |
| Lot Number | 0118 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2018-12-11 |